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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06452342
Other study ID # 24-5178.0
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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)

Study Design


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
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