Clinical trial · Interventional
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
NCT05820126CI-TRIAL-00092928CoVeRTS-HMrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold-stored platelet concentrate | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cold-stored platelet concentrate
- description
- Cold-stored, pathogen-reduced platelet transfusion
- interventionNames
- Biological: Cold-stored platelet concentrate
- type
- OTHER
- label
- Room temperature-stored platelet concentrate
- description
- Room temperature-stored, pathogen reduced platelet transfusion
- interventionNames
- Biological: Cold-stored platelet concentrate
Primary outcomes (2)
- measure
- Average Enrollment
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.