Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias (NCT07125508) | Clinical Trial Compass
CompletedPhase 2/3
Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias
United States40 participantsStarted 2023-08-01
Plain-language summary
The goal of this clinical trial is to learn if oral tranexamic acid works to treat gastrointestinal angioectasias. It will also learn about the safety of tranexamic acid. The main questions it aims to answer are:
Does tranexamic improve hemoglobin concentration and/or requirement for blood transfusions
What medical problems do participants have when taking tranexamic acid?
Researchers will compare tranexamic acid to a placebo (a look-alike substance that contains no drug) to see if it works to treat angioectasias.
Participants will:
Take tranexamic acid or a placebo three times per day, every day for 3 months Visit the clinic once per month for checkups and tests
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male, female, non-gender conforming patients aged \>18 years with symptomatic anemia attributed to chronic gastrointestinal blood loss from angioectasias despite endoscopic ablation and iron therapy
* Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria:
* Contraindications to tranexamic acid (TXA) therapy
* Allergy to TXA, intracranial bleed, history of venous or arterial thromboembolism, active thromboembolic disease, ischemic retinopathy
* Bleeding/Coagulopathy disorder and/or on anticoagulation regimen
* Ulcerative colitis or Crohn's disease
* End stage renal disease
* Decompensated cirrhosis
* Pregnancy or intention to become pregnant
* Patient refusal of blood products because the secondary outcome is pre-determined
* Unable to give formal consent
* Participation in another interventional study where primary outcome includes hemoglobin/hematocrit values
* Inability to adhere to treatment regimen for 3 months
* Non-English speaking
* Patients \< 18 years old
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement
Timeframe: From enrollment to the end of treatment at 3 months
Trial details
NCT IDNCT07125508
SponsorLouisiana State University Health Sciences Center in New Orleans