Nebulized tranexamic acid to stop post-tonsillectomy bleeding in children
Official title: TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study
Run by The University of Texas Health Science Center at San Antonio · NCT07565753 · Data updated 2026-11-12
This study tests if breathing in a fine TXA mist can quickly stop bleeding after tonsil removal in kids, potentially reducing the need for additional procedures.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 3 sites (Davis, California and 2 other locations) |
| Status | Recruiting |
| Started | July 14, 2026 |
| Main results expected | September 30, 2027 |
| Study ends | September 30, 2028 |
| Registry record updated | July 17, 2026 |
| Trial ID | NCT07565753 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2–17 who have secondary post-tonsillectomy hemorrhage within 24 hours of arrival and have no bleeding/clotting disorders, no known TXA allergy, and can communicate in English or Spanish.
✕Probably not a fit
Patients with known bleeding disorders, prior enrollment in this study, or intolerance to tranexamic acid may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase trial enrolls children aged 2 to 17 years who develop secondary post-tonsillectomy hemorrhage. It administers three consecutive nebulized doses of tranexamic acid, adjusted by weight (500 mg per dose for ≥25 kg, 250 mg per dose for <25 kg), delivered over about one hour. The intervention is given in a hospital or clinic setting by trained clinicians using a nebulizer. Primary aim is to see if neb TXA can control bleeding rapidly without surgical intervention. The trial is sponsored by UT Health San Antonio with NHLBI collaboration and includes multiple sites in California, Rhode Island, and Texas.
Why it matters
Potential benefit: If successful, participants may stop the bleeding without needing another surgery or blood transfusion, leading to quicker recovery.
How similar studies have gone: Previous studies in similar settings suggest tranexamic acid can help control bleeding, but this specific nebulized, pediatric, post-tonsillectomy context is investigational.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Received a tonsillectomy 2. Presents to the ED with secondary\* post-tonsillectomy hemorrhage 3. Children between age of 2 to 17 years of age (i.e., before their 18th birthday) \*Secondary post-tonsillectomy hemorrhage is defined as greater than 24 hours from their primary tonsillectomy operation (arrival in recovery/PACU). Exclusion Criteria: 1. Known and documented bleeding or clotting disorder. 2. Known pregnancy. 3. Patients with known hypersensitivity or allergic response to tranexamic acid. 4. Parents or guardians who cannot communicate in English or Spanish. 5. Intubation prior to enrollment. 6. Previously enrolled patients.
Where it's running
-
University of California at Davis Medical Center
Davis, California, United States Recruiting -
Hasbro Childrens' Hospital
Providence, Rhode Island, United States Not yet recruiting -
University Hospital
San Antonio, Texas, United States Not yet recruiting
Study contacts
- Principal investigator: Andrew D Meyer, MD, MS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Andrew D Meyer, MD, MS
- Email: meyera@uthscsa.edu
- Phone: 210-567-4424
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.