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Trial Title:
Cold Versus Room Temperature Storage of Platelets for Bleeding in Hematologic Malignancy - a Pilot Trial
NCT ID:
NCT05820126
Condition:
Hematologic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Intervention model description:
Single center, Blinded, Randomized Controlled Trial
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
The investigator and participant will both be blinded to the study treatment (whether
they receive cold stored vs. room temperature stored platelets)
Intervention:
Intervention type:
Biological
Intervention name:
Cold-stored platelet concentrate
Description:
Patients will be transfused a unit of pooled, pathogen reduced platelets that have been
stored for >24 hours at 1-6˚C
Arm group label:
Cold-stored platelet concentrate
Arm group label:
Room temperature-stored platelet concentrate
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 5, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ottawa Hospital Research Institute
Agency class:
Other
Source:
Ottawa Hospital Research Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05820126
