Clinical trial NCT06580509: TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage
Official title: TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Pilot and Feasibility Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Hemorrhage, Surgical
Tonsillar Bleeding
Keywords: Tranexamic Acid
Nebulizer
Post tonsillectomy hemorrhabe
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arm randomized, double-blind, controlled clinical trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Received a tonsillectomy
2. Presents to the ED with secondary\* post-tonsillectomy hemorrhage
3. 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).

Exclusion Criteria:

1. Known and documented bleeding or clotting disorder.
2. Known pregnancy.
3. Patients with known hypersensitivity or allergic response to tranexamic acid.
4. Parents or guardians who cannot communicate in English or Spanish.
5. Intubation prior to enrollment.
6. Previously enrolled patients.

Primary outcomes:
measure: Number of patients enrolled per month
timeFrame: Baseline to 18 months (or duration of study)
measure: Number of nebulizations per patient
timeFrame: Baseline to 18 months (or duration of study)
measure: Indirect local concentration of nebulized TXA
timeFrame: Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours.
measure: Systemic Concentration of nebulized TXA
timeFrame: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.
Secondary outcomes:
measure: Number of return visits to the OR
timeFrame: Baseline to 18 months (or duration of study)
measure: Estimated blood loss
timeFrame: Baseline to 7 days
measure: Number of recurrences of PTH
timeFrame: Baseline to 18 months (or duration of study)
measure: Number of blood transfusions required
timeFrame: Baseline to 18 months (or duration of study)
Other outcomes:
measure: Wong-Baker FACES Pain Rating Scale
timeFrame: Day 1, 7 and 30
measure: State-Trait Anxiety Inventory (STAI) for Adults
timeFrame: Day 1 and day 7 plus or minus one day.
measure: State-Trait Anxiety Inventory for Children (STAIC)
timeFrame: Day 1 and Day 7 (plus or minus one day)
Locations:
city: San Antonio
country: United States
facility: University Hospital
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Andrew D Meyer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: