TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study

NCT06580509 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00000638
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

Tranexamic Acid; Nebulizer; Post tonsillectomy hemorrhage

Outcome Measures

Primary Outcomes (4)

• Number of patients enrolled per month

  Assess target enrollment of patients per site per month.

  Baseline to 18 months (or duration of study)

• Number of nebulizations per patient

  Evaluate the ability to nebulize at least two doses of TXA to children with PTH

  Baseline to 18 months (or duration of study)

• Indirect local concentration of nebulized TXA

  Limited data on nebulized TXA systematic absorption. Topical PK studies of TXA document a significant reduction in systematic levels but the same hemostasis effect. Collection of two blood samples from each participant. This will verify a pulmonary physiological-based PK model (PBPK) (i.e., nasal cavity, pharynx, and lung) that indirectly predicts the oropharyngeal and systematic concentration of nebulized TXA.

  Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours.

• Systemic Concentration of nebulized TXA

  Pharmacokinetics samples will be collected after completion of the last nebulized treatment received within sixty minutes. A second time point should then be collected after sixty minutes up to eight hours from last nebulization, separated from the previous time point by at least sixty to ninety minutes. The serum TXA levels will be used to verify a TXA Physiological-based Pharmacokinetic model and determine the population variability. This PBPK model is built by our research pharmacist based on extensive research already completed on TXA distribution and metabolism. Once the model is built, the investigators only need a one to two samples to determine if the model accurately reflects collect samples. The investigators will develop a base model to determine a best-fit compartmental model, distribution, and elimination kinetics. The investigators will also use stochastic models to evaluate between-subject variability in PK parameters.

  Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.

Secondary Outcomes (4)

• Number of return visits to the OR

  Baseline to 18 months (or duration of study)

• Estimated blood loss

  Baseline to 7 days

• Number of recurrences of PTH

  Baseline to 18 months (or duration of study)

• Number of blood transfusions required

  Baseline to 18 months (or duration of study)

Other Outcomes (3)

• Wong-Baker FACES Pain Rating Scale

  Day 1, 7 and 30

• State-Trait Anxiety Inventory (STAI) for Adults

  Day 1 and day 7 plus or minus one day.

• State-Trait Anxiety Inventory for Children (STAIC)

  Day 1 and Day 7 (plus or minus one day)

Study Arms (2)

Nebulized Tranexamic Acid

EXPERIMENTAL

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

Drug: Tranexamic Acid Injectable Product

Nebulized Saline

PLACEBO COMPARATOR

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

Other: Normal Saline

Interventions

Tranexamic Acid Injectable Product DRUG

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.

Also known as: TXA 100mg/ml

Nebulized Tranexamic Acid

Normal Saline OTHER

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.

Also known as: 0.9% saline solution

Nebulized Saline

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University Hospital

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Blood Loss, Surgical

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andrew D Meyer, MD, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew D Meyer, MD, MS

CONTACT

210-567-4424; meyera@uthscsa.edu

Stephanie Perez, MHA

CONTACT

(210) 450-8973; perezs11@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To maintain blinding, all personnel except the investigational pharmacist and/or statistician will be unaware of the administered drug. The randomization schedule will be pre-determined by a central randomization process and prepared as "use next boxes" to streamline the process at enrollment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two arm randomized, double-blind, controlled clinical trial

Study Record Dates

• First Submitted: August 29, 2024
• First Posted: August 30, 2024
• Study Start: February 18, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data from this study may be requested by other researchers 3 years after the completion of the primary endpoint by contacting Andrew D. Meyer, MD, MS or through the DCC public use dataset website.

Locations

US (1)