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Completed

NCT Number: NCT07125508

Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias

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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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

LSU Health Sciences Center - New Orleans

New Orleans, Louisiana, 70112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tranexamic Acid (TXA) treatment

Drug

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

Drug

Placebo intervention

Primary outcomes

  1. Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement

    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

Secondary outcomes

  1. Number of Participants with Treatment-Related Adverse Events

    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

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias: A Randomized, Placebo Controlled Trial

Acronym: TAMBA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 15, 2025
Registry last updated
Aug 15, 2025

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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