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

NCT06452342 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 24-5178.0
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Participant recruitment to study

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

  3 months

Secondary Outcomes (3)

• Participant adherence to the study drug

  3 months

• Participant compliance with study procedures

  3 months

• Loss to follow-up or drop-out

  3 months

Other Outcomes (11)

• Menstrual blood loss per menstrual cycle

  3 months

• Menstrual blood loss in days

  3 months

• Menstrual blood loss in days with PBAC > 5

  3 months

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic acid

No tranexamic acid

OTHER

Routine clinical care without Tranexamic acid

Other: No Tranexamic acid

Interventions

Tranexamic acid DRUG

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

Also known as: Cyclokapron

Tranexamic acid

No Tranexamic acid OTHER

Routine clinical care without Tranexamic acid

No tranexamic acid

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
• Diagnosed with acute VTE on objective imaging;
• Within two weeks of starting treatment with therapeutic dose anticoagulation;
• Planned treatment of at least 3 months of therapeutic dose anticoagulation.
• Written informed consent in accordance with federal, local and institutional guidelines.

You may not qualify if:

• Hypersensitivity or allergy to TXA
• Active major bleeding other than menstrual bleeding
• Use of hormonal contraceptives
• 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.
• Known renal insufficiency
• Pregnant or breastfeeding
• Use of other thrombotic agents
• Under 18 years of age
• Patient is unable to provide informed consent (lacking capacity, language etc)

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network: collaborator

MeSH Terms

Conditions

Venous Thromboembolism; Venous Thrombosis; Menorrhagia; Hemostatic Disorders

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Hematologist

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 11, 2024
• Study Start: June 1, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share