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

Venous Thromboembolism Clinical Trial

— T-REX HMB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06452342
• Other study ID #: 24-5178.0
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: June 2024
• Est. completion date: April 2026

Study information

• Verified date: June 2024
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anticoagulants and Bleeding Disorders
• Blood Coagulation Disorders
• Heavy Menstrual Bleeding
• Hemorrhage
• Hemostatic Disorders
• Menorrhagia
• Thromboembolism
• Thrombosis
• Venous Thromboembolism
• Venous Thromboses
• Venous Thrombosis

Intervention

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

Other:
• No Tranexamic acid
Routine clinical care without Tranexamic acid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Menstrual blood loss in days	Menstrual blood loss in days, over total study follow up time;	3 months
Other	Menstrual blood loss in days with PBAC > 5	Menstrual blood loss in days with PBAC > 5, over total study follow up time	3 months
Other	Major bleeding events	As defined by the International Society on Thrombosis and Haemostasis (ISTH)	3 months
Other	Clinically relevant non-major bleeding	As defined by the International Society on Thrombosis and Haemostasis (ISTH)	3 months
Other	Ferritin	Ferritin blood work	3 months
Other	Hemoglobin	Hemoglobin blood work	3 months
Other	Recurrent venous thromboembolism	Objectively confirmed on appropriate diagnostic imaging	3 months
Other	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
Other	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
Other	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
Primary	Participant recruitment to study	Number of participants successfully recruited to the study and randomized to a treatment arm	3 months
Secondary	Participant adherence to the study drug	Defined as the proportion of menstrual days in which TXA was taken	3 months
Secondary	Participant compliance with study procedures	Defined as >75% study drug adherence and no missed follow up visits	3 months
Secondary	Loss to follow-up or drop-out		3 months