Healthy
Conditions
Keywords
red blood cells, transfusion, recovery, feasibility, white blood cell inactivation
Brief summary
Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood
Detailed description
Radiolabeling of red blood cells (RBCs) followed by infusion back to the donor is commonly used to test the quality of RBCs in a person. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.
Interventions
BIOLOGICALMirasol System for Whole Blood.
Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects
Sponsors
United States Department of Defense
Terumo BCTbio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* healthy adults who meet AABB (formerly known as the American Association of Blood Banks) criteria for whole blood donation * females incapable of becoming pregnant * males agreeing to use contraception during trial
Exclusion criteria
* pregnancy or nursing * abnormal medical history (bleeding disorders, anemia, myocardial ischemia, uncontrolled hypertension, heart disease, epilepsy) * major surgery * use of drugs affecting coagulation or RBC function * recent participation in other trials which may confound results
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Red Blood Cell (RBC) Recovery | 24-hour post autologous infusion of RBCs | The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival | 28-days post autologous infusion of RBCs | The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted. |
| Count of Participants With Serious Adverse Events (SAE) | 28-days post autologous infusion of RBCs | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mirasol Illumination Dose #1 (A1) Whole blood units treated with Mirasol at Illumination dose #1: 22 J/mL RBC
Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects | 4 |
| Mirasol Illumination Dose #2 (A2) Whole Blood units treated with Mirasol at Illumination dose #2: 33 J/mL RBC
Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects | 4 |
| Mirasol Illumination Dose #3 (A3) Whole Blood units treated with Mirasol at Illumination dose #3: 44 J/mL RBC
Mirasol System for Whole Blood.: Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects | 4 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawn; health exclusion (flu) | 0 | 0 | 1 |
Baseline characteristics
| Characteristic | Mirasol Illumination Dose #1 (A1) | Mirasol Illumination Dose #2 (A2) | Mirasol Illumination Dose #3 (A3) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 3 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 46 years STANDARD_DEVIATION 7 | 42 years STANDARD_DEVIATION 18 | 51 years STANDARD_DEVIATION 13 | 46 years STANDARD_DEVIATION 13 |
| Diastolic Blood Pressure (mmHg) | 76 mmHg STANDARD_DEVIATION 5 | 69 mmHg STANDARD_DEVIATION 7 | 76 mmHg STANDARD_DEVIATION 13 | 74 mmHg STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height (inches) | 69 inches STANDARD_DEVIATION 4 | 70 inches STANDARD_DEVIATION 3 | 68 inches STANDARD_DEVIATION 3 | 69 inches STANDARD_DEVIATION 3 |
| Oral Temperature degrees Fahrenheit (F) | 98 degrees Fahrenheit (F) STANDARD_DEVIATION 0.6 | 97 degrees Fahrenheit (F) STANDARD_DEVIATION 0.3 | 97 degrees Fahrenheit (F) STANDARD_DEVIATION 0.4 | 97 degrees Fahrenheit (F) STANDARD_DEVIATION 0.5 |
| Pulse (bpm) | 68 bpm STANDARD_DEVIATION 5 | 68 bpm STANDARD_DEVIATION 3 | 72 bpm STANDARD_DEVIATION 11 | 69 bpm STANDARD_DEVIATION 7 |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 12 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Systolic Blood Pressure (mmHg) | 123 mmHg STANDARD_DEVIATION 11 | 112 mmHg STANDARD_DEVIATION 11 | 122 mmHg STANDARD_DEVIATION 16 | 119 mmHg STANDARD_DEVIATION 13 |
| Weight (lbs) | 219 lbs STANDARD_DEVIATION 26 | 180 lbs STANDARD_DEVIATION 17 | 253 lbs STANDARD_DEVIATION 62 | 217 lbs STANDARD_DEVIATION 48 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 1 / 4 | 2 / 4 | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 4 |
Outcome results
Primary
Red Blood Cell (RBC) Recovery
The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.
Time frame: 24-hour post autologous infusion of RBCs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Illumination Dose #1 (A1) | Red Blood Cell (RBC) Recovery | 77.8 percentage of recovered RBCs | Standard Deviation 3.4 |
| Mirasol Illumination Dose #2 (A2) | Red Blood Cell (RBC) Recovery | 70.5 percentage of recovered RBCs | Standard Deviation 7.5 |
| Mirasol Illumination Dose #3 (A3) | Red Blood Cell (RBC) Recovery | 68.1 percentage of recovered RBCs | Standard Deviation 6.3 |
Secondary
Count of Participants With Serious Adverse Events (SAE)
Time frame: 28-days post autologous infusion of RBCs
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Mirasol Illumination Dose #1 (A1) | Count of Participants With Serious Adverse Events (SAE) | 0 Participants |
| Mirasol Illumination Dose #2 (A2) | Count of Participants With Serious Adverse Events (SAE) | 0 Participants |
| Mirasol Illumination Dose #3 (A3) | Count of Participants With Serious Adverse Events (SAE) | 0 Participants |
Secondary
Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted.
Time frame: 28-days post autologous infusion of RBCs
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mirasol Illumination Dose #1 (A1) | Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival | 75.9 days | Standard Deviation 17.8 |
| Mirasol Illumination Dose #2 (A2) | Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival | 66.9 days | Standard Deviation 31 |
| Mirasol Illumination Dose #3 (A3) | Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival | 55.9 days | Standard Deviation 20.6 |