AnemiaPhase 2/3TAMBANCT07125508
Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias
A Phase 2/3 study testing Tranexamic Acid (TXA) treatment in people with Anemia and Small Bowel Bleeding, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anemia, Small Bowel Bleeding, Angioectasias
- What is being tested?
- Tranexamic Acid (TXA) treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2023to 15 Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
United States1 site
LSU Health Sciences Center - New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias: A Randomized, Placebo Controlled Trial
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
Read the 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
- Being tested
- Tranexamic Acid (TXA) treatment, Placebo
- Keywords
- tranexamic acid, angioectasia
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid (TXA) treatmentDrug
Also called TXA
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.
PlaceboDrug
Placebo intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (1)
Number of Participants with Treatment-Related Adverse Events
To determine the rate of clinically significant side effects associated with TXA therapy leading to drug withdrawal
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2025
- Study start1 Aug 2023
- Primary completion1 Sep 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07125508
- Sponsor's protocol ID
- IRB # 4587
- Acronym
- TAMBA
- Status last verified
- Aug 2025
- First submitted
- 31 Jul 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tranexamic Acid for The Management of Bleeding Gastrointestinal Angioectasias: A Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT07125508
- Acronym / sponsor ID
- TAMBA / IRB # 4587
- Conditions
- Anemia, Small Bowel Bleeding, Angioectasias
- Keywords
- tranexamic acid, angioectasia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 15 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tranexamic Acid | Active comparator | Drug: Tranexamic Acid (TXA) treatmentPatients 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 | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid (TXA) treatmentAlso: TXAPatients 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 |
| PlaceboPlacebo intervention | Drug | Placebo |
Primary outcome
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
1 secondary outcome
Number of Participants with Treatment-Related Adverse Events
Time frame: From enrollment to the end of treatment at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tranexamic Acid (TXA) treatment in people with Anemia and Small Bowel Bleeding, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with improved hemoglobin concentrations and/or blood transfusions requirement (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.