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

Phase 4Not Yet RecruitingNCT06452342

University Health Network, Toronto20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Venous Thromboembolism Venous Thromboses Heavy Menstrual Bleeding Anticoagulants and Bleeding Disorders

Tranexamic acidDRUG

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

No Tranexamic acidOTHER

Routine clinical care without Tranexamic acid

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Participant recruitment to study

Number of participants successfully recruited to the study and randomized to a treatment arm

Time frame: 3 months

Secondary Outcomes

Participant adherence to the study drug

Defined as the proportion of menstrual days in which TXA was taken

Time frame: 3 months

Participant compliance with study procedures

Defined as \>75% study drug adherence and no missed follow up visits

Time frame: 3 months

Loss to follow-up or drop-out

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes