NCT06452342

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tranexamic acid	Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period
OTHER	No Tranexamic acid	Routine clinical care without Tranexamic acid

Timeline

• Start date: 2024-06-01
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2024-06-11
• Last updated: 2024-06-12