Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)

Last updated: September 20, 2023
Sponsor: Ottawa Hospital Research Institute
Overall Status: Active - Recruiting

Phase

3

Condition

Hematologic Neoplasms

Treatment

Tranexamic Acid

Clinical Study ID

NCT04448184
2068
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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

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 lastmonth 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 normalor fibrinogen less than 2 g/L
  9. Previously documented history of refractoriness to platelet transfusion secondary toHLA antibodies (Refractoriness is defined as 2 consecutive ABO matched platelettransfusions 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 normalor 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 tocongenital colour blindness)
  14. Participant has known sensitivity or allergy to Tranexamic Acid or any of itsingredients

Study Design

Total Participants: 662
Treatment Group(s): 1
Primary Treatment: Tranexamic Acid
Phase: 3
Study Start date:
February 16, 2022
Estimated Completion Date:
February 28, 2027

Study Description

In Canada, over 1,500 autologous hematopoietic stem cell transplantations (ASCT) are performed annually for hematologic malignancies. It is currently standard practice to provide a prophylactic transfusion of platelets to prevent bleeding when the daily measured platelet count is less than 10 x 109/L. A patient may require up to six adult platelet doses during the post-transplant period. However, the true benefit of prophylactic platelet transfusions in the ASCT setting is unclear and has been called into question by several recent studies.

Prophylactic platelet transfusions may not only be unnecessary, they may be detrimental to the patient. Among blood products, platelet transfusions are associated with the highest risk of both infectious and non-infectious complications: this would include bacterial infections and allergic /febrile reactions. Moreover, the potential overuse of platelet products places a significant burden on a scarce health care resource that is provided through volunteer donations.

An alternative strategy to prevent bleeding and reduce the need for platelet transfusions involves administering Tranexamic Acid, an antifibrinolytic agent to stabilize blood clots and reduce bleeding. Tranexamic Acid is safe and effective in many clinical scenarios, and may be a reasonable alternative for prophylactic platelet transfusions. In the setting of ASCT, Tranexamic Acid may reduce bleeding and further enhance a strategy of therapeutic platelet transfusions where platelets are administered only in the event of active bleeding symptoms.

The effect of prophylactic platelet transfusions and Tranexamic Acid on clinical, quality of life and economic outcomes in patients receiving ASCT is unknown. The primary aim of this research program is to perform a randomized controlled trial to determine whether a strategy of prophylactic Tranexamic Acid (with therapeutic platelet transfusions) is safe and effective compared to prophylactic platelet transfusions in patients undergoing ASCT.

A pilot trial demonstrated feasibility by successfully recruiting 100 patients and these patients will be rolled over into the phase III study. The treatment assignment and bleeding outcomes for these patients remain blinded.

Connect with a study center

  • Tom Baker Cancer Centre

    Calgary, Alberta T2N4N2
    Canada

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta
    Canada

    Active - Recruiting

  • University of Manitoba

    Winnipeg, Manitoba
    Canada

    Site Not Available

  • Eastern Regional Health Authority

    Saint John's, Newfoundland and Labrador A1B 3V6
    Canada

    Active - Recruiting

  • Memorial University

    St. John's, Newfoundland and Labrador
    Canada

    Site Not Available

  • Dalhousie University

    Halifax, Nova Scotia
    Canada

    Site Not Available

  • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

    Hamilton, Ontario L8V 1C3
    Canada

    Active - Recruiting

  • London Health Sciences Centre

    London, Ontario N6A5W9
    Canada

    Active - Recruiting

  • The Ottawa Hospital

    Ottawa, Ontario K1H8L6
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Hopital Maisonneuve-Rosemont

    Montréal, Quebec
    Canada

    Site Not Available

  • Saskatchewan Cancer Agency

    Saskatoon, Saskatchewan
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.