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| Name | Class |
|---|---|
| Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period. |
|
| No tranexamic acid | Other | Routine clinical care without Tranexamic acid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic acid | Drug | Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant recruitment to study | Number of participants successfully recruited to the study and randomized to a treatment arm | 3 months |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Menstrual blood loss in days |
Inclusion Criteria:
Exclusion Criteria:
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| No Tranexamic acid | Other | Routine clinical care without Tranexamic acid |
|
| 3 months |
| Loss to follow-up or drop-out | 3 months |
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 |
| 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 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D020246 | Venous Thrombosis |
| D008595 | Menorrhagia |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013927 | Thrombosis |
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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