Healthy
Conditions
Keywords
INTERCEPT, Recovery, Survival, 7 days, Radiolabeled, Autologous
Brief summary
The principle objective of this study is to evaluate the hypothesis that INTERCEPT Platelets in 100% plasma stored for 5 or more days (up to 7 days) after apheresis collection retain sufficient viability for therapeutic transfusion efficacy. The post-infusion recovery and survival of autologous radiolabeled 7 day INTERCEPT platelets (Test) stored in 100% plasma will be measured in comparison to fresh autologous radiolabeled platelets (Control) according to FDA guidance for platelet testing (FDA 1999) in Stage 2 of this study protocol. A secondary objective is to compare the recovery and survival results for Test platelets prepared for radiolabeling using the procedures outlined by the Biomedical Excellence for Safer Transfusion Collaboration (BEST) or a variation of the BEST procedure (referred to as Variant 1) in Stage 1 of this study protocol. Cerus has demonstrated that the Variant 1 method, which does not incorporate an initial soft spin in the presence of ACD A, results in improved in vitro platelet recovery and quality during preparation for radiolabeling compared to the BEST procedure. This comparison will evaluate the hypothesis that preparation methods prior to radiolabeling may influence in vitro quality of the radiolabeled platelets and post-infusion viability outcomes.
Detailed description
The study will be performed in two stages. Stage 1 is a randomized, 2-period crossover design. Test platelets stored for 7 days will be radiolabeled based on either the BEST or Variant 1 methods (depending on the period and randomization scheme for the Test platelets) for 12 healthy subjects. The recovery and survival for Test platelets prepared with the BEST and Variant 1 methods will be compared with each other and against the fresh platelet Control. With agreement from the FDA (BQ200481, July 8, 2020), completion of Stage 1 is not required. Stage 2 is a single arm design. Test platelets from 24 healthy subjects, stored for 7 days, will be prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets will be compared against the fresh platelet Control. Stage 1 subjects with evaluable Variant 1 method data will contribute to the requirement of the 24 subjects for Stage 2. For both stages, the study population will consist of healthy subjects who meet the FDA, AABB, and site-specific research donor eligibility criteria for apheresis platelet donation. Apheresis platelets will be collected in 100% plasma on the Trima Accel® Automated Blood Collection system. Each study apheresis collection will be processed using the INTERCEPT Blood System for Platelets. Platelet components containing 3.0 to 7.9 x10\^11 platelets in 300 to 420 mL of plasma will be processed using the INTERCEPT Dual Storage (DS) set. The INTERCEPT process will begin on either the day of collection (Day 0) or the day following donation (Day 1); illumination must occur within 24 hours after the end of collection. Test platelets components will be stored for up to 7 days, from day of collection, in 100% plasma. During each stage samples for in vitro platelet testing will be collected prior to INTERCEPT treatment (Day 0/1), post INTERCEPT treatment and at the end of storage, Day 7 (see In vitro evaluation of platelets below). At the end of storage, an aliquot of Test platelets will be aseptically removed from each subject's INTERCEPT platelet storage container for preparation of samples for radiolabeling using either the BEST (Stage 1) or Variant 1 (Stages 1 and 2) methodology. The in vitro quality of the Test platelet sample used for radiolabeling will be assessed prior to and following the pre-radiolabeling platelet sample preparations. The indices to be measured in Stage 1 are volume, pH22°C, CD62P, platelet count, red blood cell (RBC) count and white blood cell (WBC) count. Assessments of these indices will enable the determination of platelet processing recovery for each sample preparation method and evaluation of RBC and WBC contamination in samples prior to radiolabeling. In Stage 2 platelet processing recovery during sample preparation will be calculated from volume and platelet count and pH22°C, will be measured in the sample prior to radiolabeling. On the day corresponding to the end of storage for the Test component, healthy subjects will return to the site, and 43 mL of whole blood (WB) will be drawn into a syringe containing 9 mL of Anticoagulant Citrate Dextrose Solution, Formula A (ACD A). The sample will be used to prepare Control platelets following the BEST methodology. Test and Control platelets will be randomly radiolabeled with either 51Cr (approximately10-30μCi) as sodium radiochromate (Na251CrO4) or 111In (approximately 10-30 μCi) as indium oxine, depending upon the randomization assignment and period as applicable. Subjects will be randomized with equal probability to the radiolabeling sequences (111In/51Cr vs. 51Cr/111In) for Test/Control. The isotope labels will be assigned randomly with equal probability that Control and Test platelets will be labeled with each isotope, and the same randomization assignment of isotope labels will be utilized for both apheresis collections for the same subject in Stage 1. After radiolabeling, the autologous Control and Test platelet samples will be simultaneously infused into the subject (approximately 10 30 mL). A negative pregnancy test for females of childbearing potential is required before infusion. Blood samples will be drawn immediately before infusion and for radioactivity measurements at 1 hour ± 15 min and 2 hours ± 15 min post-infusion (Day 0), and 6 more samples will be drawn at 1, 2, 3, 4 (or 5 or 6), 7 or 8, and 11±1 days post-infusion (DPI), at approximately the same time of day as the radiolabeled platelet infusion was administered (±4 hours). The exact time of each sample draw will be recorded. For subjects enrolled in Stage 1, there will be a minimum washout period of four weeks between the two study periods (e.g., four weeks after the last blood sample at 11±1 DPI, in Period 1). Subjects will be monitored for safety (adverse events) from the first apheresis procedure until 24 hours after the last DPI blood sample is drawn.
Interventions
Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7days at 20-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets (approximately 10-30 mL) will be simultaneously administered intravenously into the subject.
Sponsors
Cerus Corporation
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than or equal to 18 years, of either gender. * Normal health status (as determined by the Investigator review of medical history and blood donor physical exam). * Meet FDA, AABB, and site guidelines for blood donation and apheresis platelet donation. Travel, tattoos/piercings and/or male to male sexual contact deferrals do not apply. * Complete blood count (CBC) and serum chemistry values within established reference ranges or within guidelines as above. * Pre-donation platelet count of more than 150×10\^9 platelets/ L. * Negative blood donor screening test panel for HIV, HBV, HCV, HTLV, syphilis, and WNV. * Subjects of childbearing potential must agree to use a medically acceptable method of contraception throughout the study. A barrier method of contraception must be included, regardless of other methods. * Signed and dated informed consent form.
Exclusion criteria
* For participation in Stage 2, received any previous infusion in this study. * Clinically significant acute or chronic disease (as determined by the Investigator). * Pregnant or nursing females. * Subjects of childbearing potential not using effective contraception. * Disease states or conditions that preclude apheresis platelet donation per AABB reference standards. * Treatment with aspirin or aspirin-containing medications within 7 days of apheresis or treatment with non-steroidal anti-inflammatory drugs (NSAID), anti-platelet agents (or other drugs affecting platelet viability within 3 days of apheresis (e.g., ibuprofen or other NSAIDs). * Subject received platelet inhibitors within 14 days of donation (e.g., clopidogrel, ticlopidine, amphetamines (e.g., Adderall, Dexedrine)). * Subjects with positive cocaine and/or amphetamine results from urine drug screen. * Splenectomized subjects. * History of known hypersensitivity to indium or chromium. * Has received an investigational drug within the past 28 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets | Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero. |
| Post Infusion Survival of Test Platelets at End of Storage | 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets | Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pH 22°C | At the end of storage on Day 7 | Percentage of Test components with pH 22°C ≥ 6.2 |
| Platelet Yield Retention | At the end of INTERCEPT treatment on Day 1 or Day 2 | Percentage of Test components with ≥80% platelet yield retention |
| Platelet Dose in Test Component | At the end of INTERCEPT treatment on Day 1 or Day 2 | Percentage of Test components with ≥ 3.0×10\^11 platelets |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2 | At the end of storage on Day 7 | pO2 was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2 | At the end of storage on Day 7 | pO2 normalized for platelet count was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2 | At the end of storage on Day 7 | pCO2 was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2 | At the end of storage on Day 7 | pCO2 was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3 | At the end of storage on Day 7 | HCO3 was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3 | At the end of storage on Day 7 | HCO3 was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose | At the end of storage on Day 7 | Supernatant glucose was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose | At the end of storage on Day 7 | Supernatant glucose was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate | At the end of storage on Day 7 | Supernatant lactate was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate | At the end of storage on Day 7 | Supernatant lactate was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP | At the end of storage on Day 7 | Total ATP was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP | At the end of storage on Day 7 | Total ATP was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology | At the end of storage on Day 7 | The morphology score quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher morphology scores represent healthier platelets. Morphology was summarized descriptively for Stage 1 and Stage 2 Test components. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change | At the end of storage on Day 7 | The Extent of Shape Change is a measurement of agonist-induced, disc-to-sphere shape change of platelets using an aggregometer. It is a quantitative assessment of the proportion of platelets that have discoid morphology in a platelet suspension. Higher values indicate better platelet quality. An aggregometer instrument is to make this measurement. Extent of Shape Change was summarized descriptively for Stage 1 and Stage 2 Test components. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response | At the end of storage on Day 7 | Hypotonic Shock Response is used as an index of platelet integrity and metabolic homeostasis. An aggregometer instrument was used to measure the ability of platelets to recover their volume after being exposed to a hypotonic environment. Higher values of Hypotonic Shock Response indicate better platelet quality. Hypotonic Shock Response was summarized descriptively for Stage 1 and Stage 2 Test components. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity | At the end of storage on Day 7 | Supernatant levels of LDH in PCs represent normal plasma LDH plus LDH released by platelets through cell leakage and injury. Supernatant LDH activity was summarized descriptively for Stage 1 and Stage 2 Test components. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH | At the end of storage on Day 7 | Supernatant LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity | At the end of storage on Day 7 | Total LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH | At the end of storage on Day 7 | Supernatant LDH Proportion of Total LDH, ratio of LDH supernatant to the total LDH, was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis | At the end of storage on Day 7 | For calculation of baseline adjusted lysis the baseline/input supernatant LDH is subtract from the Day 7 supernatant LDH; the lysis is calculated from from the Day 7 adjusted supernatant LDH and Day 7 total LDH values. Baseline Adjusted Lysis was summarized descriptively for Stage 1 and Stage 2 Test components. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P) | At the end of storage on Day 7 | Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. P-selectin was measured by flow cytometry and was summarized descriptively for Stage 1 and Stage 2 Test components. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component | Day 7 | Stage 1 and Stage 2 sample volume from platelet component was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count | Day 7 | Stage 1 and Stage 2 platelet count was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery) | Day 7 | In vitro physical platelet recovery is expressed as the percentage of platelets that are remaining after preparation of the Test sample for radiolabeling, prior to addition of the radiolabel, compared to the number of platelets that were present prior to sample preparation. This measurement shows the loss of platelets during the sample preparations and also provides a process control parameter to ensure that the platelet sample used for radiolabeling is representative of the platelet population in the entire platelet component. Stage 1 and Stage 2 Platelet Yield (Physical Recovery) was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80% | Day 7 | The percentage of Stage 1 and Stage 2 samples with physical recovery ≥ 80% was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C | Day 7 | Stage 1 and Stage 2 pH 22°C was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2 | Day 7 | The percentage of Stage 1 and Stage 2 samples with pH 22°C ≥ 6.2 was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count | Day 7 | The Red Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count | Day 7 | The White Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1. |
| In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P) | Day 7 | Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. Measurement of P-selectin prior to radiolabeling allows assessment of the amount of platelet activation induced by the sample preparation process when compared to the Day 7 P-selectin levels in the platelet component. The P-selectin expression (CD62P) was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1. |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count | At the end of storage on Day 7 | Platelet count was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume | At the end of storage on Day 7 | Component volume was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose | At the end of storage on Day 7 | Platelet dose was summarized descriptively for Stage 1 and Stage 2 Test components |
| Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV | At the end of storage on Day 7 | MPV was summarized descriptively for Stage 1 and Stage 2 Test components |
Countries
United States
Participant flow
Recruitment details
A subject was considered enrolled upon signing the informed consent form.
Pre-assignment details
Subjects who initiated an apheresis collection were included in the Safety Analysis Set. Subjects with paired Test and Control in vivo recovery and survival data were included in the Evaluable Analysis Set. Data from subjects who completed a Variant 1 arm of Stage 1 was included as part of the Stage 2 analysis.
Participants by arm
| Arm | Count |
|---|---|
| Stage 1 Stage 1 was comprised of a randomized 2-arm, 2-period crossover design (Period 1 and Period 2). Each subject was randomized to Arm 1 or 2 of the study to determine which methodology was used in Period 1 and Period 2 to prepare and radiolabel the Test platelets. In Arm 1, Test platelets were radiolabeled using the Variant 1 method in Period 1 and the BEST method in Period 2. Test platelets in Arm 2 were radiolabeled using the BEST method in Period 1 and the Variant 1 method in Period 2.
Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days.
The recovery and survival for Test platelets was compared against the fresh platelet Control.
A subject was considered enrolled upon signing the informed consent form. Demographics are summarized for the Safety Analysis Set which was comprised all subjects who initiated an apheresis collection for Stage 1. | 15 |
| Stage 2 Stage 2 was comprised of a single period. Test platelets were derived from apheresis platelet components in 100% plasma, collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets and stored for 7 days. On Day 7 Test platelets were prepared for radiolabeling following the Variant 1 methodology. The recovery and survival for Test platelets was compared against the fresh platelet Control. A subject was considered enrolled upon signing the informed consent form. Safety Analysis Set which comprised all subjects who initiated an apheresis collection; the Safety Analysis Set for Stage 2 comprised 12 Stage 1 subjects with evaluable Variant 1 method data and 17 new Stage 2 subjects. Demographics are summarized for the 17 new Stage 2 subjects. | 17 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Stage 1: Period 1 | Adverse Event | 1 | 0 | 0 |
| Stage 1: Period 1 | Platelet component did not meet input specifications | 1 | 0 | 0 |
| Stage 1: Period 2 | Site closure due to COVID-19 pandemic | 1 | 1 | 0 |
| Stage 2 | Adverse Event | 0 | 0 | 2 |
| Stage 2 | Ineligible for apheresis donation | 0 | 0 | 2 |
| Stage 2 | Protocol Violation | 0 | 0 | 1 |
| Stage 2 | Screen Failure | 0 | 0 | 3 |
| Stage 2 | Site closure due to COVID-19 pandemic | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Stage 2 | Stage 1 | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 15 Participants | 31 Participants |
| Age, Continuous | 40.9 years STANDARD_DEVIATION 16.2 | 36.5 years STANDARD_DEVIATION 14.2 | 38.9 years STANDARD_DEVIATION 15.2 |
| Blood Type A | 6 participants | 7 participants | 13 participants |
| Blood Type AB | 1 participants | 0 participants | 1 participants |
| Blood Type B | 0 participants | 2 participants | 2 participants |
| Blood Type O | 10 participants | 6 participants | 16 participants |
| BMI | 29 kg/m^2 | 29 kg/m^2 | 29 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 13 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 172 cm STANDARD_DEVIATION 7 | 180 cm STANDARD_DEVIATION 8 | 176 cm STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 14 Participants | 29 Participants |
| Region of Enrollment United States | 17 participants | 15 participants | 32 participants |
| Rh Factor Negative | 2 participants | 3 participants | 5 participants |
| Rh Factor Positive | 15 participants | 12 participants | 27 participants |
| Sex: Female, Male Female | 5 Participants | 3 Participants | 8 Participants |
| Sex: Female, Male Male | 12 Participants | 12 Participants | 24 Participants |
| Weight | 85 kg STANDARD_DEVIATION 16 | 93 kg STANDARD_DEVIATION 16 | 88 kg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 15 | 0 / 17 |
| other Total, other adverse events | 8 / 13 | 11 / 15 | 10 / 17 |
| serious Total, serious adverse events | 0 / 13 | 0 / 15 | 0 / 17 |
Outcome results
Primary
Post Infusion Recovery of Test Platelets at End of Storage (Day 7)
Recovery of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>66% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test-0.66\*Control) in survival is greater than or equal to zero.
Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets
Population: The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 39.5 percentage of infused platelets | Standard Deviation 10.3 |
| Stage 1 - Variant 1 Arm - CONTROL | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 57.8 percentage of infused platelets | Standard Deviation 11.6 |
| Stage 1 - BEST Arm- TEST | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 39.1 percentage of infused platelets | Standard Deviation 10.6 |
| Stage 1 - BEST Arm - CONTROL | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 60.4 percentage of infused platelets | Standard Deviation 10.5 |
| Stage 2 - TEST | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 37.6 percentage of infused platelets | Standard Deviation 8.4 |
| Stage 2 - CONTROL | Post Infusion Recovery of Test Platelets at End of Storage (Day 7) | 56.8 percentage of infused platelets | Standard Deviation 9.2 |
95% CI: [-3.5, 6.2]
95% CI: [-6.4, 4.8]
95% CI: [-5, 8.7]
95% CI: [-2.5, 2.6]
Primary
Post Infusion Survival of Test Platelets at End of Storage
Survival of Test platelets stored for 7 Days as compared to fresh controls. In vivo recovery was expressed as proportion of infused in days and was estimated using a multiple-hit model. The FDA acceptance criteria for survival is \>58% of control with the lower bound of a two-sided 95% CI for the mean treatment difference (Test - 0.58 \* Control) in survival is greater than or equal to zero.
Time frame: 11 days (+/- 1 day) post infusion of radiolabeled Test platelets stored for 7 days and fresh Control platelets
Population: The Evaluable Analysis Set (EAS) comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation. EAS was the primary analysis population for the efficacy evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Post Infusion Survival of Test Platelets at End of Storage | 150.1 hours | Standard Deviation 21.6 |
| Stage 1 - Variant 1 Arm - CONTROL | Post Infusion Survival of Test Platelets at End of Storage | 208.9 hours | Standard Deviation 15.8 |
| Stage 1 - BEST Arm- TEST | Post Infusion Survival of Test Platelets at End of Storage | 143.2 hours | Standard Deviation 33.6 |
| Stage 1 - BEST Arm - CONTROL | Post Infusion Survival of Test Platelets at End of Storage | 202.9 hours | Standard Deviation 24.4 |
| Stage 2 - TEST | Post Infusion Survival of Test Platelets at End of Storage | 151.4 hours | Standard Deviation 20.1 |
| Stage 2 - CONTROL | Post Infusion Survival of Test Platelets at End of Storage | 209.6 hours | Standard Deviation 13.9 |
95% CI: [18.5, 39.4]
95% CI: [9.5, 41.6]
95% CI: [-12.7, 15.8]
95% CI: [21.8, 37.8]
Secondary
pH 22°C
Percentage of Test components with pH 22°C ≥ 6.2
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | pH 22°C | 13 Participants |
| Stage 1 - Variant 1 Arm - CONTROL | pH 22°C | 13 Participants |
| Stage 1 - BEST Arm- TEST | pH 22°C | 23 Participants |
Secondary
Platelet Dose in Test Component
Percentage of Test components with ≥ 3.0×10\^11 platelets
Time frame: At the end of INTERCEPT treatment on Day 1 or Day 2
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Platelet Dose in Test Component | 12 Participants |
| Stage 1 - Variant 1 Arm - CONTROL | Platelet Dose in Test Component | 13 Participants |
| Stage 1 - BEST Arm- TEST | Platelet Dose in Test Component | 22 Participants |
Secondary
Platelet Yield Retention
Percentage of Test components with ≥80% platelet yield retention
Time frame: At the end of INTERCEPT treatment on Day 1 or Day 2
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Platelet Yield Retention | 12 Participants |
| Stage 1 - Variant 1 Arm - CONTROL | Platelet Yield Retention | 12 Participants |
| Stage 1 - BEST Arm- TEST | Platelet Yield Retention | 22 Participants |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis
For calculation of baseline adjusted lysis the baseline/input supernatant LDH is subtract from the Day 7 supernatant LDH; the lysis is calculated from from the Day 7 adjusted supernatant LDH and Day 7 total LDH values. Baseline Adjusted Lysis was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis | 4.7 - % of cell free LDH increased from base | Standard Deviation 2.7 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis | 4.6 - % of cell free LDH increased from base | Standard Deviation 2.9 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Baseline Adjusted Lysis | 4.4 - % of cell free LDH increased from base | Standard Deviation 2.9 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume
Component volume was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume | 334 mL | Standard Deviation 17 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume | 338 mL | Standard Deviation 12 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Component Volume | 330 mL | Standard Deviation 20 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change
The Extent of Shape Change is a measurement of agonist-induced, disc-to-sphere shape change of platelets using an aggregometer. It is a quantitative assessment of the proportion of platelets that have discoid morphology in a platelet suspension. Higher values indicate better platelet quality. An aggregometer instrument is to make this measurement. Extent of Shape Change was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change | 18.3 percentage of extent of shape change | Standard Deviation 6.7 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change | 21.5 percentage of extent of shape change | Standard Deviation 8.2 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Extent of Shape Change | 16.8 percentage of extent of shape change | Standard Deviation 5.5 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3
HCO3 was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3 | 7.4 mmol/L | Standard Deviation 2.3 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3 | 7.0 mmol/L | Standard Deviation 1.7 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: HCO3 | 7.1 mmol/L | Standard Deviation 2.1 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response
Hypotonic Shock Response is used as an index of platelet integrity and metabolic homeostasis. An aggregometer instrument was used to measure the ability of platelets to recover their volume after being exposed to a hypotonic environment. Higher values of Hypotonic Shock Response indicate better platelet quality. Hypotonic Shock Response was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response | 45.8 percentage of hypotonic shock response | Standard Deviation 14.2 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response | 53.4 percentage of hypotonic shock response | Standard Deviation 9.1 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Hypotonic Shock Response | 48.6 percentage of hypotonic shock response | Standard Deviation 16.9 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology
The morphology score quantifies (via phase-contrast light microscopy) the morphological changes of platelets coincident with the full range of platelet activation profile (Units: Kunicki score; Range is 0 to 400). Higher morphology scores represent healthier platelets. Morphology was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology | 327 score on a scale | Standard Deviation 21 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology | 326 score on a scale | Standard Deviation 31 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Morphology | 324 score on a scale | Standard Deviation 22 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV
MPV was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV | 7.3 fL | Standard Deviation 0.6 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV | 7.2 fL | Standard Deviation 0.7 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: MPV | 7.0 fL | Standard Deviation 0.7 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3
HCO3 was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3 | 6.8 mmol/10^12 platelets | Standard Deviation 2.7 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3 | 6.5 mmol/10^12 platelets | Standard Deviation 1.6 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized HCO3 | 6.5 mmol/10^12 platelets | Standard Deviation 2.5 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2
pCO2 was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2 | 7.4 µmol/hrs/10^12 platelets | Standard Deviation 1 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2 | 7.8 µmol/hrs/10^12 platelets | Standard Deviation 0.6 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pCO2 | 7.3 µmol/hrs/10^12 platelets | Standard Deviation 1.3 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2
pO2 normalized for platelet count was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2 | 43.5 µmol/hrs/10^12 platelets | Standard Deviation 10.6 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2 | 42.4 µmol/hrs/10^12 platelets | Standard Deviation 7.3 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized pO2 | 42.5 µmol/hrs/10^12 platelets | Standard Deviation 8.4 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose
Supernatant glucose was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose | 11.3 mmol/10^12 platelets | Standard Deviation 4.2 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose | 11.1 mmol/10^12 platelets | Standard Deviation 2 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Glucose | 11.2 mmol/10^12 platelets | Standard Deviation 4.4 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate
Supernatant lactate was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate | 10.7 mmol/10^12 platelets | Standard Deviation 3.4 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate | 10.4 mmol/10^12 platelets | Standard Deviation 3.1 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant Lactate | 11.1 mmol/10^12 platelets | Standard Deviation 2.8 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH
Supernatant LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH | 222 U/10^12 platelets | Standard Deviation 87 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH | 220 U/10^12 platelets | Standard Deviation 62 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Supernatant LDH | 217 U/10^12 platelets | Standard Deviation 90 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP
Total ATP was normalized for platelet count and summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP | 3.2 nmol/10^8 platelets | Standard Deviation 2 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP | 2.8 nmol/10^8 platelets | Standard Deviation 1.5 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Normalized Total ATP | 3.5 nmol/10^8 platelets | Standard Deviation 1.7 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2
pCO2 was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2 | 26.5 mm Hg | Standard Deviation 3.1 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2 | 27.4 mm Hg | Standard Deviation 2.3 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: pCO2 | 26.3 mm Hg | Standard Deviation 2.8 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count
Platelet count was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count | 1116 ×10^3 platelets/µL | Standard Deviation 185 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count | 1086 ×10^3 platelets/µL | Standard Deviation 112 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Count | 1133 ×10^3 platelets/µL | Standard Deviation 176 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose
Platelet dose was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose | 3.7 ×10^11 platelets | Standard Deviation 0.7 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose | 3.7 ×10^11 platelets | Standard Deviation 0.4 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Platelet Dose | 3.7 ×10^11 platelets | Standard Deviation 0.5 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2
pO2 was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2 | 152.2 mm Hg | Standard Deviation 7.6 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2 | 147.2 mm Hg | Standard Deviation 13.8 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: pO2 | 152.3 mm Hg | Standard Deviation 8.3 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P)
Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. P-selectin was measured by flow cytometry and was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P) | 44.7 percentage of CD62P platelets | Standard Deviation 19.4 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P) | 45.3 percentage of CD62P platelets | Standard Deviation 18.2 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: P-selectin (CD62P) | 52.2 percentage of CD62P platelets | Standard Deviation 16.5 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose
Supernatant glucose was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose | 12.0 mmol/L | Standard Deviation 2.4 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose | 12.0 mmol/L | Standard Deviation 2.2 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Glucose | 12.2 mmol/L | Standard Deviation 3.9 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate
Supernatant lactate was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate | 11.6 mmol/L | Standard Deviation 3.1 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate | 11.1 mmol/L | Standard Deviation 2.8 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate | 12.3 mmol/L | Standard Deviation 2.8 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity
Supernatant levels of LDH in PCs represent normal plasma LDH plus LDH released by platelets through cell leakage and injury. Supernatant LDH activity was summarized descriptively for Stage 1 and Stage 2 Test components.
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity | 238 U/L | Standard Deviation 70 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity | 235 U/L | Standard Deviation 54 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant Lactate Dehydrogenase (LDH) Activity | 238 U/L | Standard Deviation 86 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH
Supernatant LDH Proportion of Total LDH, ratio of LDH supernatant to the total LDH, was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH | 10.7 percentage of cell free LDH to total LDH | Standard Deviation 3.1 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH | 10.6 percentage of cell free LDH to total LDH | Standard Deviation 3.3 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Supernatant LDH Proportion of Total LDH | 10.1 percentage of cell free LDH to total LDH | Standard Deviation 3.4 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP
Total ATP was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP | 3.5 µmol/dL | Standard Deviation 2.1 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP | 3.0 µmol/dL | Standard Deviation 1.5 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total ATP | 4.0 µmol/dL | Standard Deviation 2 |
Other Pre-specified
Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity
Total LDH activity was normalized for platelet count and was summarized descriptively for Stage 1 and Stage 2 Test components
Time frame: At the end of storage on Day 7
Population: Assessed in Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity | 2278 U/L | Standard Deviation 458 |
| Stage 1 - Variant 1 Arm - CONTROL | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity | 2294 U/L | Standard Deviation 537 |
| Stage 1 - BEST Arm- TEST | Assessment of the Stored Test (INTERCEPT) Platelet Components: Total LDH Activity | 2398 U/L | Standard Deviation 482 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2
The percentage of Stage 1 and Stage 2 samples with pH 22°C ≥ 6.2 was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2 | 8 Participants |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2 | 8 Participants |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With pH 22°C ≥ 6.2 | 18 Participants |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80%
The percentage of Stage 1 and Stage 2 samples with physical recovery ≥ 80% was summarized for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80% | 11 Participants |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80% | 1 Participants |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Percentage of Samples With Physical Recovery ≥ 80% | 16 Participants |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C
Stage 1 and Stage 2 pH 22°C was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C | 6.3 pH unit | Standard Deviation 0.3 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C | 6.1 pH unit | Standard Deviation 0.4 |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: pH 22°C | 6.3 pH unit | Standard Deviation 0.2 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count
Stage 1 and Stage 2 platelet count was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count | 5368 ×10^3 platelets/µL | Standard Deviation 868 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count | 3938 ×10^3 platelets/µL | Standard Deviation 856 |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Count | 5265 ×10^3 platelets/µL | Standard Deviation 1128 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery)
In vitro physical platelet recovery is expressed as the percentage of platelets that are remaining after preparation of the Test sample for radiolabeling, prior to addition of the radiolabel, compared to the number of platelets that were present prior to sample preparation. This measurement shows the loss of platelets during the sample preparations and also provides a process control parameter to ensure that the platelet sample used for radiolabeling is representative of the platelet population in the entire platelet component. Stage 1 and Stage 2 Platelet Yield (Physical Recovery) was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery) | 85.2 percentage of physical recovery | Standard Deviation 6.8 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery) | 67.7 percentage of physical recovery | Standard Deviation 12.2 |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Platelet Yield (Physical Recovery) | 84.4 percentage of physical recovery | Standard Deviation 6.8 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P)
Measurement of P-selectin (CD62P) exposure is often used as an index of platelet activation as it is translocated from the alpha granule to the plasma membrane during platelet secretion. This is a sensitive assay to quantify platelet potential for activation. Higher levels of P-selectin indicate more activation. Measurement of P-selectin prior to radiolabeling allows assessment of the amount of platelet activation induced by the sample preparation process when compared to the Day 7 P-selectin levels in the platelet component. The P-selectin expression (CD62P) was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P) | 54.2 percentage of CD62P platelets | Standard Deviation 21.5 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: P-selectin Expression (CD62P) | 67.2 percentage of CD62P platelets | Standard Deviation 17.7 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count
The Red Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count | 212 cells | Standard Deviation 456 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Red Blood Cell Total Count | 176 cells | Standard Deviation 324 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component
Stage 1 and Stage 2 sample volume from platelet component was summarized descriptively for Test samples processed using both the BEST (Stage 1) and Variant 1 (Stage 1 and Stage 2) procedures.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component | 46.8 mL | Standard Deviation 13.8 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component | 45.4 mL | Standard Deviation 15.4 |
| Stage 1 - BEST Arm- TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: Sample Volume From Component | 42.9 mL | Standard Deviation 14.9 |
Other Pre-specified
In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count
The White Blood Cell Total Count was summarized descriptively for Test samples processed using both the BEST and Variant 1 procedures in Stage 1.
Time frame: Day 7
Population: Assessed in samples from Test components stored for 7 days for subjects in the Evaluable Analysis Set (comprised all infused subjects who had both paired (referred to Test and Control) recovery and paired survival data for the relevant study stage and/or radiolabeling method, and otherwise complied with the protocol without any other major protocol deviation).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 1 - Variant 1 Arm - TEST | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count | 2666 cells | Standard Deviation 3104 |
| Stage 1 - Variant 1 Arm - CONTROL | In Vitro Evaluation of Processed Platelet Samples Prior to Radiolabeling: White Blood Cell Total Count | 722 cells | Standard Deviation 629 |