Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial

Phase 2

Not yet recruiting

• Conditions: Hematologic Malignancy
• Interventions: Biological: Cold-stored platelet concentrate

• Registration Number: NCT05820126
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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.

Detailed Description

Patients with hematologic malignancies or marrow aplasia are at increased risk of bleeding. While prophylactic platelet transfusions reduce the risk of bleeding compared with no prophylaxis, a significant risk of bleeding remains, with 43-54% of patients with a hematologic malignancy or marrow aplasia receiving chemotherapy, immunotherapy, or hematopoietic stem cell transplant (HSCT) experiencing WHO grade 2 or higher bleeding \[Stanworth et al. NEJM 2013; Gernsheimer et al, Blood 2020\]. Improved efficacy of therapeutic platelet transfusions would benefit this patient population. In vitro data suggests that cold-stored platelets have greater hemostatic responsiveness than those stored at room temperature.

This study will evaluate the feasibility of a randomized clinical trial comparing cold- and room temperature storage in patients admitted to hospital with a hematologic malignancy or marrow aplasia. Results will inform estimates of transfusion requirements and changes in bleeding severity for power calculations, inform management of a cold-stored platelet inventory, and will provide data on the use of cold-stored platelets in the Canadian health-care setting.

Study Timeline

• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-04-14
• Study First Posted: 2023-04-19
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-30
• Last Update Posted: 2023-08-01
• Study Start: 2023-09-05
• Primary Completion: 2024-06-05
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Adult patients (age ≥ 18) admitted to Malignant Hematology ward with hematologic malignancy or marrow aplasia, undergoing chemotherapy, immunotherapy, or hematopoietic stem cell transplant
2. Moderate thrombocytopenia, platelet concentration 10-100 x109/L
3. Platelet transfusion ordered to treat bleeding

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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 >greade 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cold-stored platelet concentrate	Cold-stored platelet concentrate	Cold-stored, pathogen-reduced platelet transfusion
Room temperature-stored platelet concentrate	Cold-stored platelet concentrate	Room temperature-stored, pathogen reduced platelet transfusion

Primary Outcome Measures

Name	Time	Method
Enrollment Achieved	12 months	50 participants enrolled
Average Enrollment	12 months	1. The primary feasibility outcome is the average number of patients recruited per month.

Secondary Outcome Measures

Name	Time	Method
Eligible patients consented	12 months	Proportion of eligible patients who provide consent
Protocol Adherance	12 months	3. Proportion of patients who complete study procedures and proportion of patients who adhere to the protocol (such as appropriate platelet transfusion, bleeding severity assessment prior to transfusion and at 1-hour, 4 to 6 hours and 18-24 hours after transfusion, platelet count monitoring according to the protocol)
Expired Cold-platelets	12 months	Number of cold-stored platelet concentrates that out-date prior to transfusion
Withdrawal/ Loss to follow up	12 months	Rates of withdrawal and loss to follow-up
Non-participation	12 months	Reasons for non-participation in eligible patients