Inactivation of Whole Blood With Mirasol (IMPROVEII)

Terumo

Status and phase: Completed; Phase 1

Conditions: Focus of Study: Radiolabel Recovery and Survival of RBCs

Treatments: Device: Mirasol System for Whole Blood

Study type: Interventional

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

Identifiers

NCT01907906

CTS-0080

ERMS#12308001 (Other Grant/Funding Number)

Details and patient eligibility

About

The purpose of this study is to evaluate radiolabeled recovery and survival of autologous red blood cells (RBC), derived from Mirasol-treated fresh whole blood (WB), stored as leukoreduced packed RBC (LR-pRBC), and re-infused in healthy adult subjects

Full description

This is a feasibility level study conducted to assess the recovery and survival of autologous, radiolabeled leukoreduced packed red blood cells (LR-pRBC) derived from fresh whole blood (WB) units that have been treated with the Mirasol System for Whole Blood (Mirasol System) and stored for 21 days at 1-6°C.1

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Eligible whole blood donor
• Age ≥ 18 years, of either sex
• Able to commit to the study follow-up schedule
• Subjects must have adequate bilateral antecubital venous access for WB collection and follow-up blood draws
• Negative screening test panel for infectious diseases
• Subjects of child-bearing potential (female or male) must agree to use effective contraceptive during the course of the study per site guidelines
• Subjects must agree to report adverse events (AEs) during the required reporting period
• Negative direct antiglobulin test (DAT) with subject's RBC
• Negative indirect antiglobulin test (IAT) with subject's serum

Inclusion for radiolabeled reinfusion of LR-pRBC on Day 21 (evaluated the day of, prior to, reinfusion):

• Maintenance of healthy status
• Negative direct antiglobulin test (DAT) with subject's RBC (fresh)
• Negative indirect antiglobulin test (IAT) with subject's serum (fresh) versus autologous stored LR-pRBC
• Negative serum or urine pregnancy test in females

Exclusion criteria

• Any serious medical illness and/or therapy, including: abnormal bleeding episodes, clotting or bleeding disorder, evidence of anemia, myocardial infarction, uncontrolled hypertension, heart disease, surgery with bleeding complications, epilepsy or any major surgery (with general or spinal anesthesia) within the last 6 months
• Pregnant or nursing females; For women of childbearing potential, negative serum or urine pregnancy tests at the time of WB donation and before the reinfusion are required
• Unable to give informed consent
• Participation currently, or within the last 12 months, in another investigational trial that would potentially interfere with the analysis of this investigation (e.g., pharmaceutical)
• Have received an accumulated radiation dose that would exclude them from the study according to the local radiation safety limits established by each institution
• Inability to comply with the protocol in the opinion of the investigator

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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29 participants in 2 patient groups

Arm 1: Mirasol-treated WB then untreated WB

Experimental group

Description:

Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49

Treatment:

Device: Mirasol System for Whole Blood

Arm 2: Untreated WB then Mirasol-treated WB

Experimental group

Description:

Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured \& stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49

Treatment:

Device: Mirasol System for Whole Blood