Status:
COMPLETED
Inactivation of Whole Blood With Mirasol
Lead Sponsor:
Terumo BCTbio
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
Conditions:
Focus of Study: Radiolabel Recovery and Survival of RBCs
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01907906
Start Date
June 1 2013
End Date
May 1 2014
Last Update
August 18 2015
Active Locations (2)
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1
Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
2
Puget Sound Blood Center
Seattle, Washington, United States, 98104