Status:
NOT_YET_RECRUITING
TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Hemorrhage, Surgical
Tonsillar Bleeding
Eligibility:
All Genders
2-17 years
Phase:
EARLY_PHASE1
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 wi...
Detailed Description
The study intervention involves administering nebulized tranexamic acid (TXA) to pediatric patients with traumatic hemorrhage (PTH). The intervention consists of three consecutive doses of nebulized T...
Eligibility Criteria
Inclusion
- Received a tonsillectomy
- Presents to the ED with secondary\* post-tonsillectomy hemorrhage
- 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
- Known and documented bleeding or clotting disorder.
- Known pregnancy.
- Patients with known hypersensitivity or allergic response to tranexamic acid.
- Parents or guardians who cannot communicate in English or Spanish.
- Intubation prior to enrollment.
- Previously enrolled patients.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06580509
Start Date
February 1 2026
End Date
September 30 2028
Last Update
January 6 2026
Active Locations (1)
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1
University Hospital
San Antonio, Texas, United States, 78229