Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias (TAMBA)

Louisiana State University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Anemia; Angioectasias; Small Bowel Bleeding

Treatments: Drug: Placebo; Drug: Tranexamic Acid (TXA) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT07125508

IRB # 4587

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Tranexamic Acid

Active Comparator group

Description:

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.

Treatment:

Drug: Tranexamic Acid (TXA) treatment

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo