Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias

NCT07125508 | Completed Phase 2 FDA Drug

• 1 other identifier: IRB # 4587
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anemia; Small Bowel Bleeding; Angioectasias

Keywords

tranexamic acid; angioectasia

Outcome Measures

Primary Outcomes (1)

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

  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

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (1)

• Number of Participants with Treatment-Related Adverse Events

  From enrollment to the end of treatment at 3 months

Study Arms (2)

Tranexamic Acid

ACTIVE COMPARATOR

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.

Drug: Tranexamic Acid (TXA) treatment

Placebo

PLACEBO COMPARATOR

Patients randomized to the placebo comparator arm will take oral placebo medication three times per day for 3 months. They will have blood work drawn every month for the 3 month trial period.

Drug: Placebo

Interventions

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.

Also known as: TXA

Tranexamic Acid

Placebo DRUG

Placebo intervention

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

LSU Health Sciences Center - New Orleans

New Orleans, Louisiana, 70112, United States

Location

MeSH Terms

Conditions

Anemia

Interventions

Tranexamic Acid; Therapeutics

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 15, 2025
• Study Start: August 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 15, 2024
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)