Not Yet RecruitingPhase 4

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

20 participantsStarted 2024-06

Plain-language summary

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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Written informed consent in accordance with federal, local and institutional guidelines.

Exclusion criteria

✕. 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.
✕. Known renal insufficiency
✕. Pregnant or breastfeeding
✕. Use of other thrombotic agents
✕. Under 18 years of age

What they're measuring

Participant recruitment to study

Timeframe: 3 months

Trial details

NCT IDNCT06452342

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04

View on ClinicalTrials.gov More Venous Thromboembolism trials