RecruitingPhase 2NCT05820126
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
Sponsor
Ottawa Hospital Research Institute
Enrollment
50 participants
Start Date
May 16, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This is a pilot trial to discover the feasibility of recruiting 50 pts over the course of 12 months. The trial is testing the efficacy of using cold-stored vs. room temperature stored (current standard of care) platelets to treat bleeding in persons with hematological disorders and thrombocytopenia.
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, this may include patients undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant or patients admitted for symptom management.
- Moderate thrombocytopenia, platelet concentration 10-100 x109/L
- Platelet transfusion ordered to treat bleeding
Exclusion Criteria13
- Severe thrombocytopenia (platelet concentration <10 x 109/L)
- Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
- International normalized ratio (INR) >2.0
- Activated partial thromboplastin time (aPTT) >40 seconds
- Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
- Known congenital bleeding disorder
- History of unprovoked venous thromboembolic disease
- Transfusion of platelet concentrate for >grade 2 bleeding in preceding 24 hours
- Order for multiple platelet transfusion at once
- Refusal of blood transfusion
- Prior participation in CoVeRTS-HM trial
- Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome
- Unable or unwilling to provide informed consent
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Interventions
BIOLOGICALCold-stored platelet concentrate
Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05820126
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