Inactivation of Whole Blood With Mirasol

Completed · Phase 1

Conditions studied: Focus of Study: Radiolabel Recovery and Survival of RBCs

In brief

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

Key facts

Study ID

NCT01907906

Run by

Terumo BCTbio

People needed

29

Starts

2013-06-01

Expected to finish

2014-05-01

Last updated by the study team

2015-08-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Hoxworth Blood Center — Cincinnati, Ohio, United States
• Puget Sound Blood Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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