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

Phase 4

Not yet recruiting

• Conditions: Venous Thromboembolism; Anticoagulants and Bleeding Disorders; Venous Thromboses; Heavy Menstrual Bleeding
• Interventions: Other: No Tranexamic acid; Drug: Tranexamic acid

• Registration Number: NCT06452342
• Lead Sponsor: University Health Network, Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-10
• Study First Posted: 2024-06-11
• Last Update Posted: 2024-06-12
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No tranexamic acid	No Tranexamic acid	Routine clinical care without Tranexamic acid
Tranexamic acid	Tranexamic acid	Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period.

Primary Outcome Measures

Name	Time	Method
Participant recruitment to study	3 months	Number of participants successfully recruited to the study and randomized to a treatment arm

Secondary Outcome Measures

Name	Time	Method
Participant compliance with study procedures	3 months	Defined as \>75% study drug adherence and no missed follow up visits
Loss to follow-up or drop-out	3 months
Participant adherence to the study drug	3 months	Defined as the proportion of menstrual days in which TXA was taken