ClinicalTrials.Veeva

Menu

Inactivation of Whole Blood With Mirasol (IMPROVEII)

T

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

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

Trial contacts and locations

2

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems