Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

Study Overview
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Brief Summary
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Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

Detailed Description
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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.

Official Title
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IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Conditions
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Healthy

Intervention / Treatment
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* Biological: Mirasol System for Whole Blood.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mirasol Illumination Dose #1<br>Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs) | Biological: Mirasol System for Whole Blood.<br>* Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects<br>* Other names: Mirasol;|
| Experimental: Mirasol Illumination Dose #2<br>Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs | Biological: Mirasol System for Whole Blood.<br>* Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects<br>* Other names: Mirasol;|
| Experimental: Mirasol Illumination Dose #3<br>Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs | Biological: Mirasol System for Whole Blood.<br>* Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects<br>* Other names: Mirasol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24-hour post autologous infusion of RBCs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 28-days post autologous infusion of RBCs | 
| Count of Participants With Serious Adverse Events (SAE) |  | 28-days post autologous infusion of RBCs | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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red blood cells, transfusion, recovery, feasibility, white blood cell inactivation