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New treatment option for Hematologic Neoplasms
Official title Platelet Transfusions in Hematopoietic Stem Cell Transplantation (The PATH III Trial)
ClinicalTrials.gov ID: NCT04448184
What this study is testing
What is Tranexamic Acid?
Tranexamic Acid is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for hematologic neoplasms.
Also referred to as SteriMax Inc., Cyclokapron®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults 18 years or older undergoing ASCT for a hematologic malignancy
- Patients providing written informed consent prior to starting transplantation
You likely can't join if
- A previous WHO grade 2, 3 or 4 bleeding event within the past year
- A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
- A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
- A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
- Active angina (chest pain of presumed cardiac origin either at rest or with activity)
- Current or previous (within 2 weeks) urinary tract bleeding
See the full eligibility criteria
- Adults 18 years or older undergoing ASCT for a hematologic malignancy
- Patients providing written informed consent prior to starting transplantation
- A previous WHO grade 2, 3 or 4 bleeding event within the past year
- A previous or current unprovoked thrombotic event defined as a pulmonary embolism, deep vein thrombosis, cerebral thrombosis
- A current provoked thrombotic event (e.g. catheter-related thrombosis) within last month and/or still requiring anticoagulant treatment.
- A requirement for therapeutic anticoagulant or anti-platelet drugs during ASCT
- Active angina (chest pain of presumed cardiac origin either at rest or with activity)
- Current or previous (within 2 weeks) urinary tract bleeding
- An inherited hemostatic or thrombotic disorder
- 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
- 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...
- 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)
- Pregnant or breast-feeding
- Unwilling or unable to provide informed consent
- Participant has acquired disturbances to his/her colour vision (does not apply to congenital colour blindness)
- Participant has known sensitivity or allergy to Tranexamic Acid or any of its ingredients
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Edmonton, Alberta, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Ottawa, Ontario, Canada
- St. Catharines, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Saskatoon, Saskatchewan, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Edmonton, Alberta, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.