Healthy Volunteers
Conditions
Brief summary
The purpose of this study is to optimize collected platelet yields in single and double platelet collections, while maintaining donor postplatelet count of \>100,000/µL.
Detailed description
This is a prospective, open-label, non-randomized study to evaluate Trima Accel System modified postcount algorithm software. Platelets will be collected according to the Trima Accel System Operator's Manual. Collection procedures will include those in which: 1. a single platelet product is collected 2. a double platelet product is collected, with or without other components. Study participation will be up to 8 days. The apheresis procedure can last from 25 to 150 minutes, dependent upon the product(s) to be collected, machine configuration, donor parameters, the quality of the vascular access, and the tolerance of the donor to the citrate anticoagulant. Donors will have one apheresis procedure and follow-up with any serious adverse events for 7 days.
Interventions
DEVICETrima Accel System
Platelet Apheresis Procedure
Sponsors
Terumo BCT
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years. * Meets Blood Center criteria for blood donation and is scheduled for an apheresis procedure that includes a single or double platelet product. These criteria are based on FDA Regulations and American Association of Blood Banks (AABB) Guidelines. * Appears to have adequate venous access to obtain a postprocedure platelet count. * Has given written informed consent.
Exclusion criteria
* Has undergone a splenectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis | The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was \< 100,000 platelets/μL. |
| Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis | The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. |
Countries
United States
Participant flow
Pre-assignment details
131 volunteers signed consent and were enrolled, but 3 were screen fails and therefore did not participate in the study
Participants by arm
| Arm | Count |
|---|---|
| Single Platelet Product Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure | 65 |
| Double Platelet Product Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.
Trima Accel System: Platelet Apheresis Procedure | 63 |
| Total | 128 |
Baseline characteristics
| Characteristic | Single Platelet Product | Total | Double Platelet Product |
|---|---|---|---|
| Age, Customized Age ≥ 18 years | 65 Participants | 128 Participants | 63 Participants |
| Height (in) | 68.9 inches STANDARD_DEVIATION 3.95 | 69.0 inches STANDARD_DEVIATION 3.69 | 69.0 inches STANDARD_DEVIATION 3.43 |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Hispanic | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 56 Participants | 109 Participants | 53 Participants |
| Sex: Female, Male Female | 23 Participants | 40 Participants | 17 Participants |
| Sex: Female, Male Male | 42 Participants | 88 Participants | 46 Participants |
| Total Blood Volume (mL) | 5214.3 mililiters STANDARD_DEVIATION 905.93 | 5249.5 mililiters STANDARD_DEVIATION 824.15 | 5285.7 mililiters STANDARD_DEVIATION 735.86 |
| Weight (lbs) | 190.3 pounds STANDARD_DEVIATION 37.59 | 191.0 pounds STANDARD_DEVIATION 34.47 | 191.6 pounds STANDARD_DEVIATION 31.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 63 |
| other Total, other adverse events | 5 / 65 | 2 / 63 |
| serious Total, serious adverse events | 0 / 65 | 0 / 63 |
Outcome results
Primary
Donor Postprocedure Platelet Count Following Donation of Double Platelet Product
The primary endpoint for this study was the participant's postprocedure platelet count after completing a double platelet collection. A procedure was considered a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL.
Time frame: The blood draw to determine post procedure platelet count will occur ≥ 15 minutes after the end of apheresis
Population: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Platelet Product | Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | Success (n) | 60 Participants |
| Single Platelet Product | Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | Failure (n) | 0 Participants |
| Double Platelet Product | Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | Success (n) | 60 Participants |
| Double Platelet Product | Donor Postprocedure Platelet Count Following Donation of Double Platelet Product | Failure (n) | 0 Participants |
Comparison: Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence.
Primary
Donor Postprocedure Platelet Count Following Donation of Single Platelet Product
The primary endpoint for this study was the postprocedure participant platelet count for participants who have completed a single or double platelet collection. A procedure was a success if the participant's postprocedure platelet count was ≥ 100,000 platelets/μL. A procedure was a failure if the participant's postprocedure platelet count was \< 100,000 platelets/μL.
Time frame: The blood draw to determine postprocedure platelet count will occur ≥ 15 minutes after the end of apheresis
Population: The Full Analysis Set (FAS) included all participants that completed the study and did not meet any of the protocol exclusion criteria. A participant could only have 1 product included in the FAS. The FAS was used to examine the primary and secondary endpoints.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Single Platelet Product | Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | Failure (n) | 0 Participants |
| Single Platelet Product | Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | Success (n) | 60 Participants |
| Double Platelet Product | Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | Failure (n) | 0 Participants |
| Double Platelet Product | Donor Postprocedure Platelet Count Following Donation of Single Platelet Product | Success (n) | 60 Participants |
Comparison: Sample Size Determination:~Up to 160 participants were to be enrolled in this study to ensure 60 evaluable single platelet product collections and 60 evaluable double platelet product collections. This number was chosen to meet the FDA requirements of 95% of postprocedure participant platelet count of ≥ 100,000 platelets/μL with 95% confidence.