NCT06580509 TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study
| NCT ID | NCT06580509 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Hemorrhage, Surgical |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-18 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2026-02-18 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Andrew D Meyer, MD, MS
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
Who can join the NCT06580509 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying Hemorrhage, Surgical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06580509 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06580509 currently recruiting?
Yes, NCT06580509 is actively recruiting participants. Contact the research team at meyera@uthscsa.edu for enrollment information.
Where is the NCT06580509 trial being conducted?
This trial is being conducted at San Antonio, United States.
Who is sponsoring the NCT06580509 clinical trial?
NCT06580509 is sponsored by The University of Texas Health Science Center at San Antonio. The principal investigator is Andrew D Meyer, MD, MS at The University of Texas Health Science Center at San Antonio. The trial plans to enroll 12 participants.