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

This study has been terminated.
(An endpoint difference between 3 energies was not observed. Correlations between recovery and ATP were established, and will be used for a Whole Blood system.)
Sponsor:
Collaborator:
Information provided by:
Terumo BCTbio
ClinicalTrials.gov Identifier:
NCT00742001
First received: August 25, 2008
Last updated: March 15, 2010
Last verified: March 2010
  Purpose

Feasibility trial to evaluate recovery and survival of RBCs from Mirasol-treated whole blood


Condition Intervention Phase
Healthy
Biological: Mirasol System for Whole Blood.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: IMPROVE: Inactivation of Whole Blood With Mirasol (R): Performance in Red Blood Cells, Platelets and Plasma Investigation

Further study details as provided by Terumo BCTbio:

Primary Outcome Measures:
  • RBC recovery [ Time Frame: 24 hr post autologous infusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • RBC survival [ Time Frame: 28 days post autologous infusion ] [ Designated as safety issue: No ]
  • SAE [ Time Frame: post autologous infusion of RBC ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2008
Study Completion Date: September 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mirasol Illumination Dose #1
Whole blood units treated with Mirasol at Illumination dose #1.
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 System
  • Mirasol
Experimental: Mirasol Illumination Dose #2
Whole Blood units treated with Mirasol at Illumination dose #2.
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 System
  • Mirasol
Experimental: Mirasol Illumination Dose #3
Whole Blood units treated with Mirasol at Illumination dose #3.
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 System
  • Mirasol

Detailed Description:

Radiolabeling of red blood cells with subsequent autologous infusion of the donor is commonly used as a surrogate to evaluate circulation of red blood cells in vivo. By measuring the level of radioisotope in a blood sample, these tests evaluate what percentage of the red blood cells remain in the bloodstream after 24 hours (recovery) and can predict how long the red blood cells will remain in circulation (survival). The IMPROVE trial is a feasibility trial to evaluate these parameters in red blood cells obtained from whole blood units that have been treated with the Mirasol System.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy adults who meet AABB 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, MI, uncontrolled hypertension, heart disease, epilepsy)
  • major surgery
  • use of drugs affecting coagulation or RBC function
  • recent participation in other trials which may confound results
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742001

Locations
United States, Ohio
University of Cincinnati, Hoxworth Blood Center
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Terumo BCTbio
Investigators
Principal Investigator: Jose Cancelas-Perez, M.D, Ph.D University of Cincinnati, Hoxworth Blood Center
  More Information

No publications provided

Responsible Party: Director of Regulatory and Clinical Affairs, CaridianBCT Biotechnologies (formerly Navigant Biotechnologies)
ClinicalTrials.gov Identifier: NCT00742001     History of Changes
Other Study ID Numbers: CTS-0040
Study First Received: August 25, 2008
Last Updated: March 15, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Terumo BCTbio:
red blood cells
transfusion
recovery
feasibility
white blood cell inactivation

ClinicalTrials.gov processed this record on April 17, 2014