TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Jun 5, 2024

Keywords

ClinConnect Summary

The T-REX HMB trial is a study looking at whether a medication called tranexamic acid (TXA) can help reduce heavy menstrual bleeding in women who are taking blood thinners for a condition called venous thromboembolism (VTE). VTE occurs when blood clots form in the veins, and while TXA has been shown to help many women with heavy periods, researchers want to see if it's safe and effective for those on anticoagulants (medications that prevent blood clots).

To participate in this trial, you need to be a pre-menopausal woman, between the ages of 18 and 74, who has regular menstrual cycles and has recently been diagnosed with VTE. You should also be starting treatment with blood thinners and plan to continue for at least three months. If you join the study, you'll be randomly assigned to receive either TXA or a placebo (a dummy treatment), and researchers will monitor your experience. However, there are some exclusions, such as having certain allergies, active major bleeding, or being pregnant. The trial is not yet recruiting participants, but it aims to gather important information that could lead to better treatments for heavy menstrual bleeding in women with VTE.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
• • 2. Diagnosed with acute VTE on objective imaging;
• • 3. Within two weeks of starting treatment with therapeutic dose anticoagulation;
• • 4. Planned treatment of at least 3 months of therapeutic dose anticoagulation.
• • 5. Written informed consent in accordance with federal, local and institutional guidelines.
• Exclusion Criteria:
• • 1. Hypersensitivity or allergy to TXA
• • 2. Active major bleeding other than menstrual bleeding
• • 3. Use of hormonal contraceptives
• • 4. 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.
• • 5. Known renal insufficiency
• • 6. Pregnant or breastfeeding
• • 7. Use of other thrombotic agents
• • 8. Under 18 years of age
• • 9. Patient is unable to provide informed consent (lacking capacity, language etc)