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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
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.
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.
University of California at Davis Medical Center
Davis, California, United States
Hasbro Childrens' Hospital
Providence, Rhode Island, United States
University Hospital
San Antonio, Texas, United States
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)
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