TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage: Pilot Study
NCT ID: NCT06580509
Last Updated: 2025-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
EARLY_PHASE1
12 participants
INTERVENTIONAL
2025-12-31
2028-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
The randomization schedule will be pre-determined by a central randomization process and prepared as "use next boxes" to streamline the process at enrollment
Study Groups
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Nebulized Tranexamic Acid
Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
Tranexamic Acid Injectable Product
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.
Nebulized Saline
Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery
Normal Saline
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.
Interventions
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Tranexamic Acid Injectable Product
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.
Normal Saline
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
2 Years
17 Years
ALL
No
Sponsors
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The University of Texas Health Science Center at San Antonio
OTHER
Responsible Party
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Principal Investigators
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Andrew D Meyer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center at San Antonio
Locations
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University Hospital
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Andrew D Meyer, MD, MS
Role: primary
Stephanie Perez
Role: backup
Other Identifiers
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STUDY00000638
Identifier Type: -
Identifier Source: org_study_id