Status:
TERMINATED
Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival
Lead Sponsor:
Terumo BCTbio
Collaborating Sponsors:
United States Department of Defense
Conditions:
Healthy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 10 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 16 2008
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00742001
Start Date
September 10 2008
End Date
December 16 2008
Last Update
August 28 2019
Active Locations (1)
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1
University of Cincinnati, Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267