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

NCT ID: NCT06452342

Last Updated: 2024-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2026-04-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Tranexamic acid

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

Group Type: EXPERIMENTAL

Tranexamic acid

Intervention Type: DRUG

Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period

No tranexamic acid

Routine clinical care without Tranexamic acid

Group Type: OTHER

No Tranexamic acid

Intervention Type: OTHER

Routine clinical care without Tranexamic acid

Interventions

Tranexamic acid

Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period

Intervention Type: DRUG

No Tranexamic acid

Routine clinical care without Tranexamic acid

Intervention Type: OTHER

Other Intervention Names

Cyclokapron

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

NETWORK

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Jameel Abdulrehman

Staff Hematologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

24-5178.0

Identifier Type: -

Identifier Source: org_study_id