Hemorrhage, SurgicalEarly Phase 1TEAPOTNCT07565753
TEAPOT Study Multisite
A Early Phase 1 study testing Tranexamic Acid Injectable Product and Normal Saline in people with Hemorrhage, Surgical and Tonsillar Bleeding, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Hemorrhage, Surgical, Tonsillar Bleeding
- What is being tested?
- Tranexamic Acid Injectable Product and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jul 2026to 30 Sep 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
University of California at Davis Medical Center
Davis, California, 95819
Daniel Nishijima, MD, dnishijima@ucdavis.edu
- Not yet recruiting
Hasbro Childrens' Hospital
Providence, Rhode Island, 02903
Thomas Chun, MD, 401-444-6680, Thomas_Chun@brown.edu
- Not yet recruiting
University Hospital
San Antonio, Texas, 78229
Andrew D Meyer, MD, MS, 210-562-5816, MEYERA@UTHSCSA.EDU
Stephanie Perez, 210-450-8973, perezs11@uthscsa.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Hemorrhage, Surgical, Tonsillar Bleeding
- Being tested
- Tranexamic Acid Injectable Product, Normal Saline
- Keywords
- Tranexamic Acid, Nebulizer, Post tonsillectomy hemorrhage
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic Acid Injectable ProductDrug
Also called TXA 100mg/ml
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 SalineOther
Also called 0.9% saline solution
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.
| Study group | Role | What they receive |
|---|---|---|
| Nebulized Tranexamic Acid | Experimental | Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery Receives: 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 Receives: Other: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients enrolled per month
Assess target enrollment of patients per site per month.
Measured: 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
Measured: Baseline to 18 months (or duration of study approximately 18 months)
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.
Measured: 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.
Measured: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.
Secondary outcomes (4)
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
Measured: Baseline to 18 months (or duration of study approximately 18 months)
Estimated blood loss
Determine the estimated blood loss per participant
Measured: Baseline to 7 days
Number of recurrences of PTH
Number of participants in which there was a recurrence of post-tonsillectomy hemorrhage after the study drug was administered
Measured: 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.
Measured: Baseline to 18 months (or duration of study approximately 18 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start14 Jul 2026
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhage, SurgicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two arm randomized, double-blind, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Andrew D. Meyer, The University of Texas Health Science Center at San Antonio
- Investigators
- Andrew D Meyer, MD, MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07565753
- Sponsor's protocol ID
- IRB# 00191036
- Other IDs
- R34HL177446
- Acronym
- TEAPOT
- Status last verified
- Jan 2026
- First submitted
- 27 Apr 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Meyer AD, Schwarz W, Erwin D, Earley M, Yellepeddi VK, Chun TH, Casper TC, Nishijima DK. TranExamic Atomized for Pediatric post-Operative Tonsillectomy hemorrhage (TEAPOT): Study protocol for a pilot randomized controlled trial. PLoS One. 2026 Jul 28;21(7):e0353841. doi: 10.1371/journal.pone.0353841. eCollection 2026.
PubMed 42520054
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study
- ClinicalTrials.gov ID
- NCT07565753
- Acronym / sponsor ID
- TEAPOT / IRB# 00191036
- Conditions
- Hemorrhage, Surgical, Tonsillar Bleeding
- Keywords
- Tranexamic Acid, Nebulizer, Post tonsillectomy hemorrhage
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 14 Jul 2026 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Two arm randomized, double-blind, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Nebulized Tranexamic Acid | Experimental | Drug: Tranexamic Acid Injectable ProductSubjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery |
| Nebulized Saline | Placebo comparator | Other: Normal SalineSubjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic Acid Injectable ProductAlso: TXA 100mg/mlParticipants 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. | Drug | Nebulized Tranexamic Acid |
| Normal SalineAlso: 0.9% saline solutionParticipants 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 | Nebulized Saline |
Primary outcome
Number of patients enrolled per month
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Assess target enrollment of patients per site per month.
Number of nebulizations per patient
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Evaluate the ability to nebulize at least two doses of TXA to children with PTH
Indirect local concentration of nebulized TXA
Time frame: Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours.
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.
Systemic Concentration of nebulized TXA
Time frame: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.
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.
4 secondary outcomes
Number of return visits to the OR
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Estimated blood loss
Time frame: Baseline to 7 days
Number of recurrences of PTH
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Number of blood transfusions required
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Derived from this study: PubMed 42520054Meyer AD, Schwarz W, Erwin D, Earley M, Yellepeddi VK, Chun TH, Casper TC, Nishijima DK. TranExamic Atomized for Pediatric post-Operative Tonsillectomy hemorrhage (TEAPOT): Study protocol for a pilot randomized controlled trial. PLoS One. 2026 Jul 28;21(7):e0353841. doi: 10.1371/journal.pone.0353841. eCollection 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew D Meyer, MD, MS principal investigator
The University of Texas Health Science Center at San Antonio
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Tranexamic Acid Injectable Product and Normal Saline in people with Hemorrhage, Surgical and Tonsillar Bleeding, run by The University of Texas Health Science Center at San Antonio at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andrew D Meyer, MD, MS (210-567-4424, meyera@uthscsa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients enrolled per month (time frame: Baseline to 18 months (or duration of study approximately 18 months)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07565753, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.