TEAPOT Study Multisite

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Другое 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.

Первичные конечные точки

• Number of patients enrolled per month [Срок оценки: Baseline to 18 months (or duration of study approximately 18 months)]
• Number of nebulizations per patient [Срок оценки: Baseline to 18 months (or duration of study approximately 18 months)]
• Indirect local concentration of nebulized TXA [Срок оценки: Immediately post nebulizer treatment (within 60 minutes) and then within 8 hours.]
• Systemic Concentration of nebulized TXA [Срок оценки: Immediately post nebulizer treatment (within 60 minutes) and up to eights hours.]

Вторичные конечные точки (4)

• Number of return visits to the OR [Срок оценки: Baseline to 18 months (or duration of study approximately 18 months)]
• Estimated blood loss [Срок оценки: Baseline to 7 days]
• Number of recurrences of PTH [Срок оценки: Baseline to 18 months (or duration of study approximately 18 months)]
• Number of blood transfusions required [Срок оценки: Baseline to 18 months (or duration of study approximately 18 months)]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• University of California at Davis Medical Center — Davis
• Hasbro Childrens' Hospital — Providence
• University Hospital — San Antonio

Публикации

• Meyer AD, Schwarz W, Erwin D, Earley M, Yellepeddi VK, Chun TH, Casper TC, Nishijima DK. TranExamic Atomized for Pediatric post-Operative Tonsillectomy hemorrhage (TEAPOT): Study protocol for a pilot randomized controlled trial. PLoS One. 2026 Jul 28;21(7):e0353841. doi: 10.1371/journal.pone.0353841. eCollection 2026. PMID 42520054

Идентификаторы

NCT: NCT07565753 · IRB# 00191036 · R34HL177446

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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