T-REX HMB is a pilot randomized controlled trial (RCT) designed to assess the feasibility of a full trial comparing tranexamic acid (TXA) to placebo in decreasing HMB in premenopausal individuals anticoagulated for VTE. Strong data supports TXA as an effective and safe agent at decreasing HMB in the general population, but its use in those with VTE has been limited by a lack of data for its efficacy in anticoagulated individuals and theoretical concerns of its prothrombotic effects.
Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
Diagnosed with acute VTE on objective imaging;
Within two weeks of starting treatment with therapeutic dose anticoagulation;
Planned treatment of at least 3 months of therapeutic dose anticoagulation.
Hypersensitivity or allergy to TXA
Active major bleeding other than menstrual bleeding
Use of hormonal contraceptives
Known history of thrombosis and antiphospholipid syndrome (including those patients that are triple positive for lupus anticoagulant, anticardiolipin antibodies, and anti-beta 2-glycoprotein I antibodies.
Parallel
Tranexamic acid
DrugTranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period
No Tranexamic acid
Other interventionRoutine clinical care without Tranexamic acid
Participant recruitment to study
Number of participants successfully recruited to the study and randomized to a treatment arm
Participant adherence to the study drug
Defined as the proportion of menstrual days in which TXA was taken
Participant compliance with study procedures
Defined as \>75% study drug adherence and no missed follow up visits
Loss to follow-up or drop-out
Menstrual blood loss per menstrual cycle
Measured by the pictorial blood loss assessment chart (PBAC). The PBAC has a minimum value of 0 and no maximum value, with a higher score indicating a worse outcome.
Menstrual blood loss in days
Menstrual blood loss in days, over total study follow up time;
Menstrual blood loss in days with PBAC > 5
Menstrual blood loss in days with PBAC \> 5, over total study follow up time
Major bleeding events
As defined by the International Society on Thrombosis and Haemostasis (ISTH)
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University Health Network, Toronto
Lead sponsor
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
