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Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
RECRUITINGPhase 2Sponsored by Ottawa Hospital Research Institute
Actively Recruiting
PhasePhase 2
SponsorOttawa Hospital Research Institute
Started2025-05-16
Est. completion2026-06-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05820126
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
Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria: 1. 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. 2. Moderate thrombocytopenia, platelet concentration 10-100 x109/L 3. Platelet transfusion ordered to treat bleeding Exclusion Criteria: 1. Severe thrombocytopenia (platelet concentration \<10 x 109/L) 2. Known platelet refractoriness requiring HLA or HPA selected platelet concentrates 3. International normalized ratio (INR) \>2.0 4. Activated partial thromboplastin time (aPTT) \>40 seconds 5. Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant) 6. Known congenital bleeding disorder 7. History of unprovoked venous thromboembolic disease 8. Transfusion of platelet concentrate for \>grade 2 bleeding in preceding 24 hours 9. Order for multiple platelet transfusion at once 10. Refusal of blood transfusion 11. Prior participation in CoVeRTS-HM trial 12. Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome 13. Unable or unwilling to provide informed consent
Conditions2
CancerHematologic Malignancy
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Actively Recruiting
PhasePhase 2
SponsorOttawa Hospital Research Institute
Started2025-05-16
Est. completion2026-06-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05820126