Venous Thromboembolism Clinical Trial
— T-REX HMBOfficial title:
TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
Verified date | June 2024 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network |
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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