TranExamic Atomized for Pediatric Post-Operative Tonsillectomy Hemorrhage (TEAPOT)

The University of Texas System (UT)

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Hemorrhage, Surgical; Tonsillar Bleeding

Treatments: Other: Normal Saline; Drug: Tranexamic Acid Injectable Product

Study type: Interventional

Funder types: Other

Identifiers

NCT06580509

STUDY00000638

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

12 participants in 2 patient groups, including a placebo group

Nebulized Tranexamic Acid

Experimental group

Description:

Subjects will be adminstered nebulized TXA post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Treatment:

Drug: Tranexamic Acid Injectable Product

Nebulized Saline

Placebo Comparator group

Description:

Subjects will be adminstered nebulized saline post-tonsillectomy if they return to the emergency room with hemorrhage after surgery

Treatment:

Other: Normal Saline