Venous ThromboembolismPhase 4T-REX HMBNCT06452342
TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
A Phase 4 study testing Tranexamic acid and No Tranexamic acid in people with Venous Thromboembolism and Venous Thromboses, run by University Health Network, Toronto.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Venous Thromboembolism, Venous Thromboses, Heavy Menstrual Bleeding
- What is being tested?
- Tranexamic acid and No Tranexamic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
- Diagnosed with acute VTE on objective imaging;
- Within two weeks of starting treatment with therapeutic dose anticoagulation;
- Planned treatment of at least 3 months of therapeutic dose anticoagulation.
- Written informed consent in accordance with federal, local and institutional guidelines.
Who cannot join
- Hypersensitivity or allergy to TXA
- Active major bleeding other than menstrual bleeding
- Use of hormonal contraceptives
- 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.
- Known renal insufficiency
- Pregnant or breastfeeding
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- Use of other thrombotic agents
- Under 18 years of age
- Patient is unable to provide informed consent (lacking capacity, language etc)
About this study
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.
- Conditions
- Venous Thromboembolism, Venous Thromboses, Heavy Menstrual Bleeding, Anticoagulants and Bleeding Disorders
- Being tested
- Tranexamic acid, No Tranexamic acid
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis, Menorrhagia, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Also called Cyclokapron
Tranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period
No Tranexamic acidOther
Routine clinical care without Tranexamic acid
| Study group | Role | What they receive |
|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period. Receives: Drug: Tranexamic acid |
| No tranexamic acid | Other | Routine clinical care without Tranexamic acid Receives: Other: No Tranexamic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant recruitment to study
Number of participants successfully recruited to the study and randomized to a treatment arm
Measured: 3 months
Secondary outcomes (3)
Participant adherence to the study drug
Defined as the proportion of menstrual days in which TXA was taken
Measured: 3 months
Participant compliance with study procedures
Defined as >75% study drug adherence and no missed follow up visits
Measured: 3 months
Loss to follow-up or drop-out
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study startJun 2024 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Responsible party
- Principal investigator, Jameel Abdulrehman, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06452342
- Sponsor's protocol ID
- 24-5178.0
- Acronym
- T-REX HMB
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRanEXamic Acid to Decrease Heavy Menstrual Bleeding in Individuals Anticoagulated for Venous Thromboembolism Pilot Study
- ClinicalTrials.gov ID
- NCT06452342
- Acronym / sponsor ID
- T-REX HMB / 24-5178.0
- Conditions
- Venous Thromboembolism, Venous Thromboses, Heavy Menstrual Bleeding, Anticoagulants and Bleeding Disorders
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network
- Study start
- Jun 2024 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic acid | Experimental | Drug: Tranexamic acidTranexamic acid (Cyclokapron®) 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period. |
| No tranexamic acid | Other | Other: No Tranexamic acidRoutine clinical care without Tranexamic acid |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult pre-menopausal individuals with regular menstrual cycles (defined as menstrual bleeding every 24 to 38 days)
- Diagnosed with acute VTE on objective imaging;
- Within two weeks of starting treatment with therapeutic dose anticoagulation;
- Planned treatment of at least 3 months of therapeutic dose anticoagulation.
- Written informed consent in accordance with federal, local and institutional guidelines.
Key exclusion criteria (9 listed)
- Hypersensitivity or allergy to TXA
- Active major bleeding other than menstrual bleeding
- Use of hormonal contraceptives
- 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.
- Known renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic acidAlso: CyclokapronTranexamic acid 1.5 grams, orally, three times a day during menstrual cycle for the 3 month study period | Drug | Tranexamic acid |
| No Tranexamic acidRoutine clinical care without Tranexamic acid | Other | No tranexamic acid |
Primary outcome
Participant recruitment to study
Time frame: 3 months
Number of participants successfully recruited to the study and randomized to a treatment arm
3 secondary outcomes
Participant adherence to the study drug
Time frame: 3 months
Participant compliance with study procedures
Time frame: 3 months
Loss to follow-up or drop-out
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tranexamic acid and No Tranexamic acid in people with Venous Thromboembolism and Venous Thromboses, run by University Health Network, Toronto.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant recruitment to study (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2024.