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

Terumo

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Biological: Mirasol System for Whole Blood.

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT00742001

CTS-0040

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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12 participants in 3 patient groups

Mirasol Illumination Dose #1

Experimental group

Description:

Whole blood units treated with Mirasol at Illumination dose #1 (A1) of 22 Joules per milliliter of red blood cells (J/mL RBCs)

Treatment:

Biological: Mirasol System for Whole Blood.

Mirasol Illumination Dose #2

Experimental group

Description:

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

Treatment:

Biological: Mirasol System for Whole Blood.

Mirasol Illumination Dose #3

Experimental group

Description:

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

Treatment:

Biological: Mirasol System for Whole Blood.