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Could a simple drug replace platelet transfusions for stem cell patients?

NCT ID NCT04448184

Disease control Sponsor: Ottawa Hospital Research Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a drug called tranexamic acid can safely replace routine platelet transfusions in adults receiving a stem cell transplant for blood cancers. About 662 participants will either get tranexamic acid or standard platelet transfusions. The goal is to see if the drug reduces bleeding and is just as safe.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tranexamic Acid
What this could lead to
If successful, this could reduce the need for platelet transfusions in stem cell transplant patients, lowering risks and costs while maintaining safety.
What could go wrong
This is a large phase 3 trial, but tranexamic acid may not prevent bleeding as well as transfusions, and there is a small risk of blood clots. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 662 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hematologic neoplasms

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cross Cancer Institute

    RECRUITING

    Edmonton, Alberta, Canada

  • Dalhousie University

    NOT_YET_RECRUITING

    Halifax, Nova Scotia, Canada

  • Eastern Regional Health Authority

    RECRUITING

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

  • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre

    RECRUITING

    Hamilton, Ontario, L8V 1C3, Canada

  • Hopital Maisonneuve-Rosemont

    NOT_YET_RECRUITING

    Montreal, Quebec, Canada

  • London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A5W9, Canada

  • Memorial University

    NOT_YET_RECRUITING

    St. John's, Newfoundland and Labrador, Canada

  • Niagara Health System

    RECRUITING

    St. Catharines, Ontario, L2S 0A9, Canada

  • Princess Margaret Cancer Centre

    WITHDRAWN

    Toronto, Ontario, M5G 2M9, Canada

  • Saskatchewan Cancer Agency

    RECRUITING

    Saskatoon, Saskatchewan, Canada

  • The Ottawa Hospital

    RECRUITING

    Ottawa, Ontario, K1H8L6, Canada

  • Tom Baker Cancer Centre

    RECRUITING

    Calgary, Alberta, T2N4N2, Canada

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