NCT Number: NCT07565753
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.
Interested in participating?
Request Info2 year–17 year
All sexes
Interventional
Early Phase 1
University of California at Davis Medical Center, Davis, California, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
Assess target enrollment of patients per site per month.
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
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.
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.
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
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 7 days
Determine the estimated blood loss per participant
Time frame: Baseline to 18 months (or duration of study approximately 18 months)
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)
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: Day 7 after randomization (plus or minus one day)
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)
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)
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.
Contact information is provided by the study sponsor or research team.
Andrew D Meyer, MD, MS
CONTACT
Stephanie Perez, MHA
CONTACT
The University of Texas Health Science Center at San Antonio
Other
TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study
Acronym: TEAPOT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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