An Early Phase 1 interventional study of Tranexamic Acid Injectable Product and Normal Saline in Hemorrhage, Surgical and Tonsillar Bleeding, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 3 sites in United States. Open to participants aged 2 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-07-17.
Sponsored by The University of Texas Health Science Center at San Antonio · Early Phase 1, Interventional, and Treatment
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.
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.
218 studies on the registry are indexed under Blood Loss, Surgical; 40 are open to participants now.
This study's planned enrollment of 30 is below the median of 90 across 157 interventional studies indexed under Blood Loss, Surgical.
Browse Blood Loss, Surgical studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
Drug: Tranexamic Acid Injectable Product
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 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
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
Number of patients enrolled per month
Assess target enrollment of patients per site per month.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.
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
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Estimated blood loss
Determine the estimated blood loss per participant
Time frame: 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
Time frame: 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.
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 7 after randomization(plus or minus one day)
Plan to share: 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.
Supporting information: Study protocol, Sap, Icf
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The University of Texas Health Science Center at San Antonio