TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study (T-REX HMB)

University Health Network, Toronto

Status and phase: Not yet enrolling; Phase 4

Conditions: Venous Thromboembolism; Anticoagulants and Bleeding Disorders; Venous Thromboses; Heavy Menstrual Bleeding

Treatments: Other: No Tranexamic acid; Drug: Tranexamic acid

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06452342

24-5178.0

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Tranexamic acid

Experimental group

Description:

Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period.

Treatment:

Drug: Tranexamic acid

No tranexamic acid

Other group

Description:

Routine clinical care without Tranexamic acid

Treatment:

Other: No Tranexamic acid