Recruiting
Phase 3

Platelet Transfusions

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04448184

Conditions

Hematologic Neoplasms

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid

Study Details

Brief summary:

It is hypothesized that a strategy using prophylactic oral and intravenous Tranexamic Acid (TXA) with therapeutic platelet transfusions (if required) is safe and more effective than prophylactic platelet transfusions in patients undergoing an autologous hematopoietic stem cell transplantation (ASCT).

Conditions

Hematologic Neoplasms

Study ID

NCT04448184

Start date

Feb 16, 2022

Status verified date

Jan, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Feb, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Adults 18 years or older undergoing ASCT for a hematologic malignancy
2. Patients providing written informed consent prior to starting transplantation

Exclusion Criteria:

1. A previous WHO grade 2, 3 or 4 bleeding event within the past year
2. A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
3. A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
4. A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
5. Active angina (chest pain of presumed cardiac origin either at rest or with activity)
6. Current or previous (within 2 weeks) urinary tract bleeding
7. An inherited hemostatic or thrombotic disorder
8. Coagulopathy defined as a prothrombin time '/International Normalization Ratio (INR) or activated partial thromboplastin time more than 1.5 times the upper limit of normal or fibrinogen less than 2 g/L
9. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies (Refractoriness is defined as 2 consecutive ABO matched platelet transfusions with platelet increment of < 7.5 and the presence of anti-HLA antibodies)
10. Significant renal impairment (creatinine more than 1.5 times the upper limit of normal or a eGFR less than 0.5 mL/min/1.78m2)
11. Pregnant or breast-feeding
12. Unwilling or unable to provide informed consent
13. Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness)
14. Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients

Study Design

Enrollment

662 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

no intervention: Prophylactic Platelet Transfusion

Patients allocated to the prophylactic platelet transfusion group will receive a platelet transfusion when the measured platelet count is less than 10 x 109/L.

experimental: Prophylactic Tranexamic Acid

Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.

Interventions

Tranexamic Acid

Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.

Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions. Subjects unable to swallow oral Tranexamic Acid pills may have the tablets crushed, administered via nasogastric (NG) tube or the medication will be administered intravenously.

Primary outcome measure

  • WHO (World Health Organization) bleeding events of Grade 2 or higher [ Time Frame: Daily, up to 30 days ]

Central Contacts and Locations

Central contacts

Locations

Tom Baker Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2N4N2

Contacts

Principal Investigator:

Jason Tay, MD

Cross Cancer Institute

Recruiting

Edmonton, Alberta, Canada

Contacts

Eastern Regional Health Authority

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 1C3

Contacts

Kylie Lepic, MD

905 521-2100

Principal Investigator:

Kylie Lepic, MD

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A5W9

Contacts

Principal Investigator:

Anargyros Xenocostas, MD

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Principal Investigator:

Alan Tinmouth, MD MSc RCPSC

Niagara Health System

Recruiting

St. Catharines, Ontario, Canada, L2S 0A9

Contacts

Principal Investigator:

Mohammad Refaei, MD

Saskatchewan Cancer Agency

Recruiting

Saskatoon, Saskatchewan, Canada

Contacts

Mohamed Elementary, MD

mohamed.elemary@saskcancer.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2026-01-08.