TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study
After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't ha
| Condition(s) | Hemorrhage, Surgical, Tonsillar Bleeding |
|---|---|
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Study type | Interventional |
| Summary | After a child has their tonsils removed, sometimes they might bleed which can be a problem. There is a special mist medicine called nebulized tranexamic acid (TXA) that might help stop the bleeding without having to touch the sore spot. If this mist works well, it could help kids get better by making sure they don't have to go back for more surgery or need blood from someone else. Not having another surgery is good because it means kids won't have to sleep under medicine again, which can sometimes be risky for their brains and breathing, and they won't feel as scared or hurt. |
| Who can participate | 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. |
| Ages | 2 Years to 17 Years |
| Sex | All |
| Lead sponsor | The University of Texas Health Science Center at San Antonio |
| Locations | San Antonio, Texas, United States |
| Start date | 2026-02-18 |
| NCT ID | NCT06580509 |
| Official listing | https://clinicaltrials.gov/study/NCT06580509 |