Clinical trial NCT06452342: TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
Official title: TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Venous Thromboembolism
Venous Thromboses
Heavy Menstrual Bleeding
Anticoagulants and Bleeding Disorders
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
First posted: 2024-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Participant recruitment to study
timeFrame: 3 months
Secondary outcomes:
measure: Participant adherence to the study drug
timeFrame: 3 months
measure: Participant compliance with study procedures
timeFrame: 3 months
measure: Loss to follow-up or drop-out
timeFrame: 3 months
Other outcomes:
measure: Menstrual blood loss per menstrual cycle
timeFrame: 3 months
measure: Menstrual blood loss in days
timeFrame: 3 months
measure: Menstrual blood loss in days with PBAC > 5
timeFrame: 3 months
measure: Major bleeding events
timeFrame: 3 months
measure: Clinically relevant non-major bleeding
timeFrame: 3 months
measure: Ferritin
timeFrame: 3 months
measure: Hemoglobin
timeFrame: 3 months
measure: Recurrent venous thromboembolism
timeFrame: 3 months
measure: Symptoms of post thrombotic syndrome
timeFrame: 3 months
measure: QOL after PE
timeFrame: 3 months
measure: General health related QOL
timeFrame: 3 months
Locations:
Study officials:
References: