Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias

NCT ID: NCT07125508

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-12-15

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

Detailed Description

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.

Conditions

Anemia; Small Bowel Bleeding; Angioectasias

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Tranexamic Acid

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.

Group Type: ACTIVE_COMPARATOR

Tranexamic Acid (TXA) treatment

Intervention Type: 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.

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo intervention

Interventions

Tranexamic Acid (TXA) treatment

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.

Intervention Type: DRUG

Placebo

Placebo intervention

Intervention Type: DRUG

Other Intervention Names

TXA

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

LSU Health Sciences Center - New Orleans

New Orleans, Louisiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

IRB # 4587

Identifier Type: -

Identifier Source: org_study_id