Anticoagulants and Bleeding Disorders, Heavy Menstrual Bleeding, Venous Thromboembolism, Venous Thromboses
Conditions
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.
Interventions
DRUGTranexamic acid
Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period
OTHERNo Tranexamic acid
Routine clinical care without Tranexamic acid
Sponsors
Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant recruitment to study | 3 months | Number of participants successfully recruited to the study and randomized to a treatment arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant adherence to the study drug | 3 months | Defined as the proportion of menstrual days in which TXA was taken |
| Participant compliance with study procedures | 3 months | Defined as \>75% study drug adherence and no missed follow up visits |
| Loss to follow-up or drop-out | 3 months | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinically relevant non-major bleeding | 3 months | As defined by the International Society on Thrombosis and Haemostasis (ISTH) |
| Ferritin | 3 months | Ferritin blood work |
| Hemoglobin | 3 months | Hemoglobin blood work |
| Menstrual blood loss per menstrual cycle | 3 months | 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. |
| Symptoms of post thrombotic syndrome | 3 months | 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. |
| QOL after PE | 3 months | 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. |
| General health related QOL | 3 months | 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. |
| Recurrent venous thromboembolism | 3 months | Objectively confirmed on appropriate diagnostic imaging |
| Menstrual blood loss in days | 3 months | Menstrual blood loss in days, over total study follow up time; |
| Menstrual blood loss in days with PBAC > 5 | 3 months | Menstrual blood loss in days with PBAC \> 5, over total study follow up time |
| Major bleeding events | 3 months | As defined by the International Society on Thrombosis and Haemostasis (ISTH) |
Outcome results
None listed