Feasibility Study of Mirasol-Treated Whole Blood Red Cell Recovery and Survival

Phase 1TerminatedNCT00742001

Terumo BCTbio12 enrolled

Overview

Feasibility trial to evaluate recovery and survival of red blood cells (RBCs) from Mirasol-treated whole blood

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 tests evaluate what percentage of the RBCs remain in the bloodstream after 24 hours (recovery) and can predict how long the RBCs will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in RBCs obtained from whole blood units that have been treated with the Mirasol System.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Healthy

Interventions

Mirasol System for Whole Blood.BIOLOGICAL

Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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

Locations (1)

University of Cincinnati, Hoxworth Blood Center

Cincinnati, Ohio, United States

Outcomes

Primary Outcomes

Red Blood Cell (RBC) Recovery

The 24-hour recovery calculation was conducted to evaluate the percentage of labeled RBCs remaining in the circulation 24 hours after re-infusion of the cells, as compared to Time 0 measurements (time of re-infusion). FDA requires at least 75% recovery for new RBC processes.

Time frame: 24-hour post autologous infusion of RBCs

Secondary Outcomes

Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival

The objective of measuring 28-day survival was to identify the potential total lifespan of labeled RBCs in circulation. Normal, native RBCs remain in circulation for a maximum of approximately 120 days; by using the 51Cr half-life of approximately 28 days, and its elution rate from labeled RBCs, the survival of the labeled cells can be predicted.

Time frame: 28-days post autologous infusion of RBCs

Count of Participants With Serious Adverse Events (SAE)

Time frame: 28-days post autologous infusion of RBCs

Data from ClinicalTrials.gov

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