Status:
TERMINATED
Efficacy and Safety of RBCs Derived From Mirasol-treated Whole Blood in Patients Requiring Chronic Transfusion (PRAISE)
Lead Sponsor:
Terumo BCTbio
Collaborating Sponsors:
United States Department of Defense
Joint Warfighter Medical Research Program
Conditions:
Transfusion Dependent Thalassemia
Eligibility:
All Genders
12+ years
Phase:
NA
Brief 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...
Detailed Description
Patients will be randomized 1:1 to receive either Mirasol-treated RBCs followed by conventional RBCs, or to receive conventional RBCs followed by Mirasol-treated RBCs. The blood centers will collect t...
Eligibility Criteria
Inclusion
- 1\. Transfusion dependent thalassemia patient with mean 2-4 week transfusion intervals for the prior 6 months.
- 2\. Age ≥ 12 years.
- 3\. Negative pregnancy test for women of childbearing potential and agreement to practice a medically acceptable contraception regimen throughout the participation in the clinical trial. Not required if female subjects are not of child-bearing potential (ie, prior to menses onset, surgically sterilized, 1-year postmenopausal).
- 4\. Signed informed consent from the patient, or if the patient is \< 18 years of age, signed assent from patient and consent from parent/guardian, according to local Institutional Review Board/Ethics Committee (IRB/EC) requirements.
Exclusion
- Historical RBC transfusion requirement of more than 250 mL/kg/year.
- Presence of RBC antibodies that make procurement of compatible RBC units not feasible per the treating physician's clinical judgment for reasonable execution of the study.
- Prior treatment with pathogen-reduced RBCs with subsequent development of known antibodies to the associated RBCs.
- Planned treatment requirement of frozen RBC products.
- Treatment requirements for any medication that is known to cause hemolysis.
- Receiving cardiac medications for heart failure.
- Patients anticipated to receive massive transfusion, per the treating physician's clinical judgment.
- Known HIV infection (defined as HIV RNA positive) with changes to antiviral regimen within the 12 months prior to screening.
- Acute or chronic medical disorder that, in the opinion of the Investigator, would impair the ability of the patient to receive study treatment.
- Participation in another clinical study, either concurrently or within the previous 28 days, in which the study drug or device may influence study endpoints or patient safety, according to Investigator discretion.
- Participation in another clinical study within the past 3 months if investigational RBCs or treatment or drugs were received that are likely to have long term effect on RBCs function.
- Pregnant or breastfeeding.
- Planned concurrent treatment with other pathogen reduction treated blood products during participation in this study.
- Patients who received prior treatment with pathogen-reduced RBCs within the past 120 days.
- Inability to comply with study procedures and/or follow-up.
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2018
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03329404
Start Date
April 12 2018
End Date
December 19 2018
Last Update
February 14 2024
Active Locations (9)
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1
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
2
Boston Children's Hospital
Boston, Massachusetts, United States, 02116
3
Weill-Cornell Medical College
New York, New York, United States, 10065
4
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104