NCT01907906CompletedPhase 1
Inactivation of Whole Blood With Mirasol : Performance in Red Blood Cells in Healthy Volunteers
Terumo BCTbio4 sites in 1 country29 target enrollmentStarted: June 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Red Blood Cell (RBC) 24-Hour Recovery
Study Overview
Brief Summary
The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects
Detailed Description
This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Eligible whole blood donor
- •Age ≥ 18 years, of either sex
- •Able to commit to the study follow-up schedule
- •Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
- •Negative screening test panel for infectious diseases
- •Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
- •Subjects must agree to report adverse events (AEs) during the required reporting period
- •Negative direct antiglobulin test (DAT) with subject's RBC
- •Negative indirect antiglobulin test (IAT) with subject's serum
- •Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):
- •Maintenance of healthy status
- •Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
- •Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
- •Negative serum or urine pregnancy test in females
Exclusion Criteria
- •Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
- •Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
- •Unable to give informed consent
- •Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)
- •Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
- •Inability to comply with the protocol in the opinion of the investigator
Outcomes
Primary Outcomes
Red Blood Cell (RBC) 24-Hour Recovery
Time Frame: 24 hours
To evaluate, as per FDA criteria, the 24-hour post transfusion RBC recovery in healthy adult subjects of leuko-reduced packed red blood cells (LR-pRBC) that have been derived from Mirasol-treated fresh WB units and stored at 1 to 6°C for 21 days. 24-hour RBC Recovery is a measure of the % of RBCs that are still functioning 24 hours after they have been reinfused back into the donor following storage over 21 days.
Secondary Outcomes
- Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) With Adenosine Triphosphate (ATP) (µmol/g Hgb)(24 hours)
- Spearman's Correlation Coefficients: 24-Hour RBC Recovery (%) pCO2 (mmHg at 37° C)(24 hours)
- Spearman's Correlation Coefficients: Linear T50 (Days) With Hemolysis (%)(28 days)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hematocrit (%)(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Hemolysis (%)(Day 21)
- Red Blood Cell (RBC) Survival by Product(28 days)
- Neoantigenicity - Day 21 Direct Antigen Test (DAT)(Day 21)
- Neoantigenicity - Day 42 Direct Antigen Test (DAT)(Day 42 of Treatment Periods 1 and 2)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - White Blood Cell (WBC) Count(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Total Hemoglobin(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pH (at 37° C)(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Potassium(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Glucose(Day 21)
- Area Under the Curve (AUC) of Red Blood Cell (RBC) Survival(28 days)
- Spearman's Correlation Coefficients: Linear T50 (Days) With pCO2 (mmHg at 37° C)(28 days)
- Neoantigenicity - Day 42 Indirect Antigen Test (IAT)(Day 42 of Treatment Periods 1 and 2)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - ATP(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - 2,3-diphosphoglycerate (DPG)(Day 21)
- Spearman's Correlation Coefficients: 24-Hour Red Blood Cell (RBC) Recovery (%) With Hemolysis (%)(24 hours)
- Spearman's Correlation Coefficients: Linear T50 (Days) With Adenosine Triphosphate (ATP) (µmol/g Hgb)(28 days)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - pCO2 (mmHg at 37° C)(Day 21)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Lactate(Day 21)
- Neoantigenicity - Day 21 Indirect Antigen Test (IAT)(Day 21 of Treatment Periods 1 and 2)
- In Vitro Results From Leuko-Reduced Packed Red Blood Cells (LR-pRBCs) - Supernatant Hgb(Day 21)
Investigators
Study Sites (4)
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