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

Hematologic Malignancy Clinical Trial

— CoVeRTS-HM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05820126
• Other study ID #: CoVeRT 4548
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: September 5, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: July 2023
• Source: Ottawa Hospital Research Institute
• Contact: Johnathan M [jmack], MD
• Phone: 6137378899
• Email: jmack[@]toh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: June 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hematologic Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Biological:
• Cold-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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Enrollment	1. The primary feasibility outcome is the average number of patients recruited per month.	12 months
Primary	Enrollment Achieved	50 participants enrolled	12 months
Secondary	Eligible patients consented	Proportion of eligible patients who provide consent	12 months
Secondary	Non-participation	Reasons for non-participation in eligible patients	12 months
Secondary	Protocol Adherance	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)	12 months
Secondary	Withdrawal/ Loss to follow up	Rates of withdrawal and loss to follow-up	12 months
Secondary	Expired Cold-platelets	Number of cold-stored platelet concentrates that out-date prior to transfusion	12 months