A Phase 4 interventional study of Tranexamic acid and No Tranexamic acid in Venous Thromboembolism, Venous Thromboses and Heavy Menstrual Bleeding, sponsored by University Health Network, Toronto. Not yet recruiting. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-06-12.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Treatment
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.
182 studies on the registry are indexed under Menorrhagia; 33 are open to participants now.
This study's planned enrollment of 20 is below the median of 100 across 133 interventional studies indexed under Menorrhagia.
Browse Menorrhagia studies →University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period.
Drug: Tranexamic acid
Routine clinical care without Tranexamic acid
Other: No Tranexamic acid
Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period
Also known as: Cyclokapron
Routine clinical care without Tranexamic acid
Participant recruitment to study
Number of participants successfully recruited to the study and randomized to a treatment arm
Time frame: 3 months
Participant adherence to the study drug
Defined as the proportion of menstrual days in which TXA was taken
Time frame: 3 months
Participant compliance with study procedures
Defined as \>75% study drug adherence and no missed follow up visits
Time frame: 3 months
Loss to follow-up or drop-out
Time frame: 3 months
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.
Time frame: 3 months
Menstrual blood loss in days
Menstrual blood loss in days, over total study follow up time;
Time frame: 3 months
Menstrual blood loss in days with PBAC > 5
Menstrual blood loss in days with PBAC \> 5, over total study follow up time
Time frame: 3 months
Major bleeding events
As defined by the International Society on Thrombosis and Haemostasis (ISTH)
Time frame: 3 months
Clinically relevant non-major bleeding
As defined by the International Society on Thrombosis and Haemostasis (ISTH)
Time frame: 3 months
Ferritin
Ferritin blood work
Time frame: 3 months
Hemoglobin
Hemoglobin blood work
Time frame: 3 months
Recurrent venous thromboembolism
Objectively confirmed on appropriate diagnostic imaging
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto