NCT05820126

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
7mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
May 2025Dec 2026

First Submitted

Initial submission to the registry

April 14, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
2.1 years until next milestone

Study Start

First participant enrolled

May 16, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

April 14, 2023

Last Update Submit

July 29, 2025

Conditions

Hematologic Malignancy

Keywords

Hematologic malignancies, bleeding, cold-stored platelets

Outcome Measures

Primary Outcomes (2)

  • Average Enrollment

    1\. The primary feasibility outcome is the average number of patients recruited per month.

    12 months

  • Enrollment Achieved

    50 participants enrolled

    12 months

Secondary Outcomes (5)

  • Eligible patients consented

    12 months

  • Non-participation

    12 months

  • Protocol Adherance

    12 months

  • Withdrawal/ Loss to follow up

    12 months

  • Expired Cold-platelets

    12 months

Study Arms (2)

Cold-stored platelet concentrate

EXPERIMENTAL

Cold-stored, pathogen-reduced platelet transfusion

Biological: Cold-stored platelet concentrate

Room temperature-stored platelet concentrate

OTHER

Room temperature-stored, pathogen reduced platelet transfusion

Biological: Cold-stored platelet concentrate

Interventions

Cold-stored platelet concentrateBIOLOGICAL

Patients will be transfused a unit of pooled, pathogen reduced platelets that have been stored for \>24 hours at 1-6˚C

Cold-stored platelet concentrateRoom temperature-stored platelet concentrate

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Moderate thrombocytopenia, platelet concentration 10-100 x109/L
  • Platelet transfusion ordered to treat bleeding

You may not qualify if:

  • Severe thrombocytopenia (platelet concentration \<10 x 109/L)
  • Known platelet refractoriness requiring HLA or HPA selected platelet concentrates
  • International normalized ratio (INR) \>2.0
  • Activated partial thromboplastin time (aPTT) \>40 seconds
  • Therapeutic anticoagulation (unfractionated heparin, low molecular weight heparin, warfarin, direct oral anticoagulant)
  • Known congenital bleeding disorder
  • History of unprovoked venous thromboembolic disease
  • Transfusion of platelet concentrate for \>grade 2 bleeding in preceding 24 hours
  • Order for multiple platelet transfusion at once
  • Refusal of blood transfusion
  • Prior participation in CoVeRTS-HM trial
  • Participation in other clinical trials with interventions that may affect CoVeRTS-HM treatment or outcome
  • Unable or unwilling to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Hematologic NeoplasmsHemorrhage

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Johnathan MAck, MD

    McGill University

    STUDY CHAIR

  • Alan Tinmouth, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johnathan M Mack, MD

CONTACT

514-934-1934johnathan.mack.med@ssss.gouv.qc.ca

Alan Tinmouth, MD

CONTACT

613-737-8899atinmouth@toh.on.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single center, Blinded, Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2023

First Posted

April 19, 2023

Study Start

May 16, 2025

Primary Completion

June 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 31, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)