TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study (T-REX HMB)

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 Overview

• Status: Not yet recruiting
• Conditions: Venous Thromboembolism; Venous Thromboses; Anticoagulants and Bleeding Disorders; Heavy Menstrual Bleeding
• Intervention / Treatment: Drug: Tranexamic acid; Other: No Tranexamic acid

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period.	Drug: Tranexamic acid; Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period; Other Names: Cyclokapron
Other: No tranexamic acid; Routine clinical care without Tranexamic acid	Other: No Tranexamic acid; Routine clinical care without Tranexamic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant recruitment to study	Number of participants successfully recruited to the study and randomized to a treatment arm	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant adherence to the study drug	Defined as the proportion of menstrual days in which TXA was taken	3 months
Participant compliance with study procedures	Defined as >75% study drug adherence and no missed follow up visits	3 months
Loss to follow-up or drop-out		3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Menstrual blood loss in days	Menstrual blood loss in days, over total study follow up time;	3 months
Menstrual blood loss in days with PBAC > 5	Menstrual blood loss in days with PBAC > 5, over total study follow up time	3 months
Major bleeding events	As defined by the International Society on Thrombosis and Haemostasis (ISTH)	3 months
Clinically relevant non-major bleeding	As defined by the International Society on Thrombosis and Haemostasis (ISTH)	3 months
Ferritin	Ferritin blood work	3 months
Hemoglobin	Hemoglobin blood work	3 months
Recurrent venous thromboembolism	Objectively confirmed on appropriate diagnostic imaging	3 months
Menstrual blood loss per menstrual cycle	Measured by the pictorial blood loss assessment chart (PBAC). The PBAC has a minimum value of 0 and no maximum value, with a higher score indicating a worse outcome.	3 months
Symptoms of post thrombotic syndrome	Symptoms of post thrombotic syndrome at 3 months using the Venous Insufficiency Epidemiological and Economic Study - Quality of Life (VEINES-QOL) survey in those with previous DVT. The VEINES-QOL survey has a minimum value of 0 and a maximum value of 118, with a higher score indicating a better outcome.	3 months
QOL after PE	QOL (quality of life) after PE at 3 months using the PEmb-QOL (Pulmonary Embolism - Quality of Life) survey in those with previous PE. The PEmb-QOL survey has a minimum value of 0 and a maximum value of 100, with a higher score indicating a worse outcome.	3 months
General health related QOL	General health related QOL using the Short Form Health Survey (SF-36). The SF-36 has a minimum value of 0 and a maximum value of 100 per health domain, with a higher score indicating a better outcome.	3 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: June 5, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 10, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Uterine Diseases; Hematologic Diseases; Hemorrhagic Disorders; Embolism and Thrombosis; Menstruation Disturbances; Uterine Hemorrhage; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Hemostatic Disorders; Blood Coagulation Disorders; Hemorrhage; Thrombosis; Venous Thrombosis; Thromboembolism; Venous Thromboembolism; Menorrhagia; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: 24-5178.0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No