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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-10

Study Completion Date

2008-12-16

Brief Summary

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

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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)

Group Type EXPERIMENTAL

Mirasol System for Whole Blood.

Intervention Type 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

Mirasol Illumination Dose #2

Whole Blood units treated with Mirasol at Illumination dose #2 (A2) of 33 J/mL RBCs

Group Type EXPERIMENTAL

Mirasol System for Whole Blood.

Intervention Type 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

Mirasol Illumination Dose #3

Whole Blood units treated with Mirasol at Illumination dose #3 (A3) of 44 J/mL RBCs

Group Type EXPERIMENTAL

Mirasol System for Whole Blood.

Intervention Type 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

Interventions

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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

Intervention Type BIOLOGICAL

Other Intervention Names

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Mirasol System Mirasol

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes