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

January 6, 2026 updated by: Ottawa Hospital Research Institute

Platelet Transfusions in Hematopoietic Stem Cell Transplantation - The PATH Phase III Trial

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
662

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sohail Robert, RN
  • Phone Number: 71892 613-737-8899
  • Email: sorobert@ohri.ca

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N4N2
        • Recruiting
        • Tom Baker Cancer Centre
        • Contact:
        • Principal Investigator:
          • Jason Tay, MD
      • Edmonton, Alberta, Canada
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Not yet recruiting
        • Memorial University
        • Contact:
          • Kirsty Tompkins, MD
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Not yet recruiting
        • Dalhousie University
        • Contact:
          • Mahmood El-Sawy, MD
    • Ontario
      • Hamilton, Ontario, Canada, L8V 1C3
        • Recruiting
        • Hamilton Health Sciences - Juravinski Hospital and Cancer Centre
        • Contact:
          • Kylie Lepic, MD
          • Phone Number: 62491 905 521-2100
        • Principal Investigator:
          • Kylie Lepic, MD
      • London, Ontario, Canada, N6A5W9
        • Recruiting
        • London Health Sciences Centre
        • Contact:
        • Principal Investigator:
          • Anargyros Xenocostas, MD
      • Ottawa, Ontario, Canada, K1H8L6
        • Recruiting
        • The Ottawa Hospital
        • Principal Investigator:
          • Alan Tinmouth, MD MSc RCPSC
        • Contact:
      • St. Catharines, Ontario, Canada, L2S 0A9
        • Recruiting
        • Niagara Health System
        • Contact:
        • Principal Investigator:
          • Mohammad Refaei, MD
      • Toronto, Ontario, Canada, M5G 2M9
        • Withdrawn
        • Princess Margaret Cancer Centre
    • Quebec
      • Montreal, Quebec, Canada
        • Not yet recruiting
        • Hôpital Maisonneuve-Rosemont
        • Contact:
          • Silvy Lachance, MD
    • Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: 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.

Other Names:
  • SteriMax Inc.
  • Cyclokapron®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
WHO (World Health Organization) bleeding events of Grade 2 or higher
Time Frame: Daily, up to 30 days
Daily, up to 30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
WHO bleeding events of Grade 3 or 4
Time Frame: Daily, up to 30 days
Daily, up to 30 days
Time from randomization to bleeding of WHO events Grade 2 or higher
Time Frame: Daily, up to 30 days
Daily, up to 30 days
Number of days with bleeding of WHO bleeding events Grade 2 or higher
Time Frame: Daily, up to 30 days
Daily, up to 30 days
Bleeding Severity Measurement Scale (BSMS) for bleeding events Grade 2 or higher
Time Frame: Daily, up to 30 days
The BSMS scale measures bleeding grade and classification from 0-2. 0 indicates no bleeding. Grade 1 bleeding consists of trace bleeding and mild bleeding and is not clinically significant. Grade 2 bleeding consists of serious bleeding, serious bleeding causing significant morbidity, and fatal bleeding. Grade 2 bleeding is clinically significant.
Daily, up to 30 days
Number of platelet and/or red blood cell transfusions
Time Frame: Daily, up to 30 days
Daily, up to 30 days
Adverse reactions related to tranexamic acid
Time Frame: Daily, up to 30 days.
Number and type of reactions will be recorded.
Daily, up to 30 days.
Venous thromboembolism grade 2 or higher
Time Frame: Daily, up to 30 days.
Daily, up to 30 days.
Adverse reactions related to platelet transfusion
Time Frame: Daily, up to 30 days.
Number and type of reactions will be recorded.
Daily, up to 30 days.
Time to platelet count recovery
Time Frame: Daily, up to 30 days.
Daily, up to 30 days.
Number of days with a platelet count < 10 x 109/L
Time Frame: Daily, up to 30 days.
Daily, up to 30 days.
LOS (Length of hospital stay)
Time Frame: LOS will be measured as the number of days elapsed between hospital admission and hospital discharge date up to 30 days.
LOS = admission date - discharge date
LOS will be measured as the number of days elapsed between hospital admission and hospital discharge date up to 30 days.
Transplant related outcome: Bearman Scoring System for Organ Toxicity following HSCT
Time Frame: Day 30
This is a validated scoring system to assess toxicity during HSCT. In this system, grade I toxicity is reversible without treatment and grade 2 is not life threatening, but requires treatment. Grade 3 requires life-support intervention and grade 4 is fatal. Regimen-related toxicity in each organ system was scored as the highest grade achieved in that organ system through day 28, except that deaths occurring after day 28 as a result of regimen-related toxicity occurring before day 28 are also scored as grade 4. Adverse events that could be attributed to infection (culture-documented), bleeding or other medications are not scored as regimen-related toxicity. The maximum toxicity is the highest grade recorded in any individual organ system and the cumulative toxicity score is the sum of the highest grades recorded for all eight organ systems.
Day 30
Transplant related outcome: Incidence of infections at Day 30 following ASCT
Time Frame: Day 30
Day 30
Transplant related outcome: Mortality at Day 30 and 180
Time Frame: Day 30, Day 180
Day 30, Day 180
Economic Analyses
Time Frame: 5 years
Incremental cost effectiveness ratios
5 years
Quality of Life Measure: FACT-Thrombocytopenia 18
Time Frame: Weekly, up to 30 days
The FACT consists of 5 subscales that measure physical well-being, functional well-being, social/family well-being and emotional well-being. The BMT subscale of the FACT includes additional items specifically designed to test quality of life and symptoms specific to transplant patients.
Weekly, up to 30 days
Quality of Life Measure: FACT- BMT
Time Frame: Day 30, Day 90, Day 180
The FACT-BMT scale is valid and sensitive to clinical change in transplant recipients. It is the most consistently used scale amongst the Canadian Bone Marrow Transplant Group (CBMTG). It is the preferred scale in several Canadian multicentre trials in stem cell transplantation. FACT- Thrombocytopenia 18 is valid measure to elicit quality of life due to thrombocytopenia, and will complement the FACT-BMT scale.
Day 30, Day 90, Day 180
Quality of Life Measure: GAD-7
Time Frame: Weekly, up to 30 days
GAD-7 is a short validated scale that assesses symptoms of generalized anxiety and is commonly used in medical settings. There is no specific validated scale to assess anxiety of patients who are at risk for bleeding.
Weekly, up to 30 days
Quality of Life Measure: EQ-5D
Time Frame: Weekly, up to 30 days
EQ-5D is a standardized measure of health status to provide a simple, generic measure of health for clinical and economic appraisal. It is applicable to a wide range of health conditions and treatments; it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care. It is cognitively undemanding, taking only a few minutes to complete.
Weekly, up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alberta Cancer Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alan Tinmouth, MD, The Ottawa Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 24, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2068

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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