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

Healthy Clinical Trial

— IMPROVE  

Official title:

IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00742001
• Other study ID #: CTS-0040
• Status: Terminated
• Phase: Phase 1
• Start date: September 10, 2008
• Est. completion date: December 16, 2008

Study information

• Verified date: August 2019
• Source: Terumo BCTbio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 16, 2008
• Est. primary completion date: November 20, 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Biological:
• Mirasol System for Whole Blood.
Treatment of whole blood with the Mirasol system at 3 experimental illumination energies for testing of autologous RBC recovery and survival in healthy subjects

Locations

Country	Name	City	State
United States	University of Cincinnati, Hoxworth Blood Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Terumo BCTbio	United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24-hour post autologous infusion of RBCs
Secondary	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.	28-days post autologous infusion of RBCs
Secondary	Count of Participants With Serious Adverse Events (SAE)		28-days post autologous infusion of RBCs