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

August 15, 2019 updated by: Terumo BCTbio

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati, Hoxworth Blood Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mirasol Illumination Dose #1
Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs)
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
Other Names:
  • Mirasol
  • Mirasol System
EXPERIMENTAL: Mirasol Illumination Dose #2
Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs
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
Other Names:
  • Mirasol
  • Mirasol System
EXPERIMENTAL: Mirasol Illumination Dose #3
Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs
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
Other Names:
  • Mirasol
  • Mirasol System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Red Blood Cell (RBC) Recovery
Time Frame: 24-hour post autologous infusion of RBCs
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Predicted Total Lifespan of Red Blood Cells (RBCs), Based on 28-day RBC Survival
Time Frame: 28-days post autologous infusion of RBCs
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
Count of Participants With Serious Adverse Events (SAE)
Time Frame: 28-days post autologous infusion of RBCs
28-days post autologous infusion of RBCs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo BCTbio

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Jose Cancelas-Perez, M.D, Ph.D, University of Cincinnati, Hoxworth Blood Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 10, 2008

Primary Completion (ACTUAL)

November 20, 2008

Study Completion (ACTUAL)

December 16, 2008

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 26, 2008

First Posted (ESTIMATE)

August 27, 2008

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 15, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CTS-0040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Mirasol System for Whole Blood.

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Congo, DR of

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe