Recruiting
Early Phase 1

Nebulized TXA

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT07565753

Conditions

Hemorrhage, Surgical

Tonsillar Bleeding

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid Injectable Product

Normal Saline

Study Details

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.

Conditions

Hemorrhage, Surgical

Tonsillar Bleeding

Study ID

NCT07565753

Start date

Jul 14, 2026

Status verified date

Jan, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nebulized Tranexamic Acid

Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

placebo comparator: Nebulized Saline

Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Interventions

Tranexamic Acid Injectable Product

Participants will receive three doses of TXA 500 mg (5 mL of TXA 100mg/ml) nebulized using a PARI LC D Disposable Nebulizer or equivalent over 10-15 minutes using 8 or greater liter/minute of gas flow.

Normal Saline

Participants will receive three 5 ml doses of placebo (normal saline) nebulized using a PARI LC D Disposable Nebulizer or equivalent over 10-15 minutes using 8 or greater liter/minute of gas flow.

Primary outcome measure

  • Number of patients enrolled per month [ Time Frame: Baseline to 18 months (or duration of study approximately 18 months) ]
  • Number of nebulizations per patient [ Time Frame: Baseline to 18 months (or duration of study approximately 18 months) ]
  • Indirect local concentration of nebulized TXA [ Time Frame: Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours. ]
  • Systemic Concentration of nebulized TXA [ Time Frame: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours. ]

Central Contacts and Locations

Central contacts

Andrew D Meyer, MD, MS

210-567-4424meyera@uthscsa.edu

Stephanie Perez, MHA

(210) 450-8973perezs11@uthscsa.edu

Locations

University of California at Davis Medical Center

Recruiting

Davis, California, United States, 95819

Contacts

Daniel Nishijima, MD

dnishijima@ucdavis.edu

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Jul 17, 2026

Last verified

Jan, 2026

Keywords

  • Tranexamic Acid
  • Nebulizer
  • Post tonsillectomy hemorrhage

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2026-07-17.