Summary

Eligibility
for people ages 2-17 (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

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.

Official Title

TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT): A Multi-center Feasibility Study

Details

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.

Keywords

Hemorrhage, Surgical, Tonsillar Bleeding, Tranexamic Acid, Nebulizer, Post tonsillectomy hemorrhage, Surgical Blood Loss, Saline Solution, Tranexamic Acid Injectable Product, Normal Saline, Nebulized Tranexamic Acid, Nebulized Saline

Eligibility

You can join if…

Open to people ages 2-17

  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).

You CAN'T join if...

  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.

Locations

  • University of California at Davis Medical Center
    Davis California 95819 United States
  • University Hospital
    San Antonio Texas 78229 United States
  • Hasbro Childrens' Hospital
    Providence Rhode Island 02903 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
The University of Texas Health Science Center at San Antonio
ID
NCT07565753
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated