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

NCT06452342 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-12

No results posted yet for this study

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

OTHER

No Tranexamic acid

Routine clinical care without Tranexamic acid

DRUG

Tranexamic acid

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

Sponsors & Collaborators

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

    collaborator NETWORK

  • University Health Network, Toronto

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-30
Primary Completion
2026-04-30
Completion
2026-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06452342 on ClinicalTrials.gov