TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage
NCT Number: NCT06580509
Acronym: TEAPOT
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: EARLY_PHASE1
Conditions: Hemorrhage, Surgical|Tonsillar Bleeding
Interventions: DRUG: Tranexamic Acid Injectable Product|OTHER: Normal Saline
Sponsor: The University of Texas Health Science Center at San Antonio
Sex: ALL
Age: CHILD
Enrollment: 12
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-10-01
Completion Date: 2028-09-30
Locations: University Hospital, San Antonio, Texas, 78229, United States

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. 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.

Primary Outcome Measures: Number of patients enrolled per month, Assess target enrollment of patients per site per month., Baseline to 18 months (or duration of study)|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)|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.
Secondary Outcome Measures: 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)|Estimated blood loss, Determine the estimated blood loss per participant, 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, Baseline to 18 months (or duration of study)|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)
Other Outcome Measures: Wong-Baker FACES Pain Rating Scale, The participant rates their pain from 0=No hurt to 10=Hurts worst, Day 1, 7 and 30|State-Trait Anxiety Inventory (STAI) for Adults, A widely used self-reported anxiety assessment instrument with versions for children over eight years of age, adolescents, and adults is the State-Trait Anxiety Inventory (STAI). The assessment is composed of two separate scales used in assessing situational (STAI-State) and baseline (STAI-Trait) anxiety levels. For more information please see https://www.mindgarden.com/145-state-trait-anxiety-inventory-for-adults.

Scale Range: Each part (State and Trait) of the STAI consists of 20 items, with scores ranging from 20 to 80. State Anxiety: Reflects how the respondent feels at a particular moment (e.g., calm, tense). Trait Anxiety: Measures how the respondent generally feels over time (e.g., relaxed, nervous).

Score Interpretation: Higher Scores: Indicate higher levels of anxiety. A score above 40 is generally considered to suggest significant anxiety symptoms.

Lower Scores: Indicate lower levels of anxiety., Day 1 and day 7 plus or minus one day.|State-Trait Anxiety Inventory for Children (STAIC), Scale Range: Similar to the adult version, the STAIC has separate scales for state and trait anxiety, each with 20 items. Scores range from 20 to 60 for each scale.

State Anxiety: Measures how children feel at the moment. Trait Anxiety: Assesses how children usually feel over time.

Score Interpretation: Higher Scores: Reflect higher levels of anxiety. A score above 30 on either scale may indicate elevated anxiety. Lower Scores: Suggest lower levels of anxiety.

Interpretation: High State Anxiety Scores: Indicate a current feeling of anxiety or stress, possibly due to a specific situation or event. High Trait Anxiety Scores: Suggest a predisposition to experiencing anxiety more frequently or intensely over time. Low Scores (Both State and Trait): Indicate calmness and a lower likelihood of anxiety, whether temporarily or as a general tendency., Day 1 and Day 7 (plus or minus one day)