TEAPOT Study Multisite (TEAPOT)

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility 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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hemorrhage, Surgical; Tonsillar Bleeding
• Intervention / Treatment: Drug: Tranexamic Acid Injectable Product; Other: Normal Saline

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 TXA.

The dosage of nebulized TXA is adjusted based on the child's weight. For children weighing more than 25 kg, each dose is 500 mg. For children weighing less than 25 kg, each dose is 250 mg.

Frequency: The three doses of nebulized TXA are administered consecutively over the course of approximately an hour. Administration Method: Nebulized TXA is delivered through a nebulizer device. A nebulizer converts the liquid medication into a fine mist or aerosol, which is then inhaled by the patient. This method allows the medication to be delivered directly to the respiratory tract, where it can exert its effect on the bleeding site. Delivery Setting: The intervention may take place in a clinical setting, such as a hospital or outpatient clinic, where nebulizer devices and medical supervision are readily available. Each patient receives three nebulized independent doses of TXA in succession. The delivery of the intervention is carried out by healthcare professionals trained in administering nebulized medications.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Andrew D Meyer, MD, MS; Phone Number: 210-567-4424; Email: meyera@uthscsa.edu
• Study Contact Backup: Name: Stephanie Perez, MHA; Phone Number: (210) 450-8973; Email: perezs11@uthscsa.edu

Study Locations

• United States
  • California
    • Davis, California, United States, 95819
      • University of California at Davis Medical Center
      • Contact: Daniel Nishijima, MD; Email: dnishijima@ucdavis.edu
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Hasbro Childrens' Hospital
      • Contact: Thomas Chun, MD; Phone Number: 401-444-6680; Email: Thomas_Chun@brown.edu
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Hospital
      • Contact: Andrew D Meyer, MD, MS; Phone Number: 210-562-5816; Email: MEYERA@UTHSCSA.EDU
      • Contact: Stephanie Perez; Phone Number: 210-450-8973; Email: perezs11@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nebulized Tranexamic Acid; Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery	Drug: 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.; Other Names: TXA 100mg/ml
Placebo Comparator: Nebulized Saline; Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery	Other: 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.; Other Names: 0.9% saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
Number of patients enrolled per month	Assess target enrollment of patients per site per month.	Baseline to 18 months (or duration of study approximately 18 months)
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 approximately 18 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss	Determine the estimated blood loss per participant	Baseline to 7 days
Number of return visits to the OR	The need for return to the Operating Room (OR) for surgical management of PTH) will be followed for up to seven days after randomization	Baseline to 18 months (or duration of study approximately 18 months)
Number of recurrences of PTH	Number of participants in which there was a recurrence of post-tonsillectomy hemorrhage after the study drug was administered	Baseline to 18 months (or duration of study approximately 18 months)
Number of blood transfusions required	Blood product transfusion volume will be measured at discharge or 24 hours (whichever comes first). This will include the volume of packed red blood cells, platelets, plasma, cryoprecipitate, or whole blood. Any mention of blood loss in electronic health records from emergency, anesthesiology, or surgeons' notes will be recorded.	Baseline to 18 months (or duration of study approximately 18 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wong-Baker FACES Pain Rating Scale or FLACC (Face, Legs, Activity, Cry, Consolability) Score	Admission of this pain scale will be age dependent, but yields the same score for the patient selection of pain or the visual cues available for pain assessment by the study team. Wong-Baker FACES Pain scale: The participant rates their pain from 0=No hurt to 10=Hurts worst, with a higher score indicating greater pain. FLACC Score: Scores 5 items from 0-2 with a total possible score of 10. A higher score indicates more pain.	Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Adults	The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.	Day 7 after randomization (plus or minus one day)
Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety scale for Children	The PROMIS Anxiety Short Form 8a is scored by summing responses to 8 items, each rated on a 5-point scale (1=Never to 5=Always) over the past 7 days, resulting in a raw score range of 8 to 40. Higher scores indicate greater anxiety severity.	Day 7 after randomization(plus or minus one day)

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Andrew D Meyer, MD, MS, The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 27, 2026
• First Posted (Actual): May 4, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Nebulizer; Tranexamic Acid; Post tonsillectomy hemorrhage
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Intraoperative Complications; Pathological Conditions, Signs and Symptoms; Blood Loss, Surgical; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions; Saline Solution
• Other Study ID Numbers: IRB# 00191036; R34HL177446 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: This study will comply with the NIH Data Sharing Policy and Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration and Results in Information Submission rule. As such, this trial will be registered at ClinicalTrials.gov, and results in information from this trial will be submitted to ClinicalTrials.gov. In addition, every attempt will be made to publish results in peer-reviewed journals.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No