Inactivation of Whole Blood With Mirasol (NCT01907906) | Clinical Trial Compass
CompletedPhase 1
Inactivation of Whole Blood With Mirasol
United States29 participantsStarted 2013-06
Plain-language 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
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…