LSU Health Sciences Center - New Orleans
New Orleans, Louisiana, 70112, United States
NCT Number: NCT07125508
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
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Interventional
Phase 2 / Phase 3
New Orleans, Louisiana, 70112, United States
Currently, the mainstay of treatment for intestinal angioectasias (AEs) includes endoscopic ablation combined with octreotide and iron supplementation. However, many patients continue to suffer from persistent or recurrent symptomatic anemia and often require repeated hospitalizations for blood transfusions. Tranexamic acid (TXA) is a hemostatic agent that has the potential to be beneficial in patients with small bowel gastrointestinal bleeding. Through a literature review multiple case reports have highlighted the impact TXA treatment can have on patients with intestinal AEs. This study would help determine the potential additive effect of TXA in patients with symptomatic anemia due to gastrointestinal AEs. Further, the researchers seek to expand the applications of TXA with the goal of decreasing morbidity and mortality.
In the randomized control trial portion of the study, the researchers will enroll approximately 50 patients with diagnosed intestinal AEs through video capsule endoscopy and/or endoscopy who experience symptomatic anemia despite standard therapy including endoscopic ablation and iron supplementation. Subjects will be randomized to either the TXA treatment group versus the placebo treatment group for 3 months. Patients will have initial complete blood counts (CBC) measured as a baseline then subsequent CBCs measured at 1, 2 and 3 months. Patients will be monitored for drug side effects, symptoms related to anemia, the need for blood transfusions and hospitalizations related to gastrointestinal bleeding/anemia.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomized to the interventional arm will take oral tranexamic acid 650 mg three times per day for 3 months. They will have blood work drawn every month for the 3 month trial period.
Other names: TXA
Placebo intervention
Time frame: From enrollment to the end of treatment at 3 months
To determine whether oral therapy with tranexamic results in improvement in serum hemoglobin concentration and/or requirement for blood transfusion compared to placebo in patients treated with standard endoscopic ablation and iron supplementation
Time frame: From enrollment to the end of treatment at 3 months
To determine the rate of clinically significant side effects associated with TXA therapy leading to drug withdrawal
Louisiana State University Health Sciences Center in New Orleans
Other
Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias: A Randomized, Placebo Controlled Trial
Acronym: TAMBA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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