Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Anemia, Small Bowel Bleeding, Angioectasias
In brief
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
Key facts
- Study ID
- NCT07125508
- Run by
- Louisiana State University Health Sciences Center in New Orleans
- People needed
- 40
- Starts
- 2023-08-01
- Expected to finish
- 2024-12-15
- Last updated by the study team
- 2025-08-15
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- LSU Health Sciences Center - New Orleans — New Orleans, Louisiana, United States
Full record on ClinicalTrials.gov
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