Hematologic Malignancy
Conditions
Keywords
Hematologic malignancies, bleeding, cold-stored platelets
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.
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
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
The investigator and participant will both be blinded to the study treatment (whether they receive cold stored vs. room temperature stored platelets). The clinical staff who will administer the platelets and complete the bleeding assessment tool will not be informed of the group assignment. The outcome assessors/adjudication committee will be blinded.
Intervention model description
Single center, Blinded, Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Enrollment | 12 months | 1\. The primary feasibility outcome is the average number of patients recruited per month. |
| Enrollment Achieved | 12 months | 50 participants enrolled |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Eligible patients consented | 12 months | Proportion of eligible patients who provide consent |
| 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 |
Countries
Canada
Contacts
Primary ContactJohnathan M Mack, MD
Backup ContactAlan Tinmouth, MD
Outcome results
None listed