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Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood in Patients Requiring Chronic Transfusion (PRAISE)

NCT03329404 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-14

Study results available
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Summary

This is a prospective, multi-center, randomized, crossover trial to evaluate the clinical effectiveness of red blood cells (RBCs) derived from Mirasol-treated whole blood (WB) versus conventional RBCs in transfusion dependent thalassemia patients. Throughout the clinical study, RBC transfusion volume and frequency will be determined by each subject's treating physician.

Conditions

  • Transfusion Dependent Thalassemia

Interventions

DEVICE

Mirasol Red Blood Cells (MIR RBCs)

Mirasol Red Blood Cells (MIR RBCs) derived from Mirasol-treated WB; WB will be Mirasol treated, centfifuged and leukoreduced and the derived RBCs will be stored before transfusion for up to 21 days and transfused according to the patient's transfusion schedule.

DEVICE

Reference Red Blood Cells (REF RBCs)

Reference Red Blood Cells (REF RBCs) will be acquired from routine use inventory and transfused according to the patient's transfusion schedule.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Joint Warfighter Medical Research Program

    collaborator OTHER

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Terumo BCTbio

    lead INDUSTRY

Principal Investigators

  • Ned Cosgriff, MD · Terumo BCT

  • Steve Sloan, MD, PhD · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-12
Primary Completion
2018-12-19
Completion
2018-12-19
FDA Device
Yes

Countries

  • United States
  • Israel
  • Italy
  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03329404 on ClinicalTrials.gov