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Идёт набор NCT07581457

Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery

Без фазы С лечением Scoliosis Idiopathic Scoliosis; Adolescence

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj, Tranexamic Acid Bolus Only.
Кому может быть актуально
Состояния в реестре: Scoliosis Idiopathic, Scoliosis; Adolescence. Базовые параметры: 10 лет — 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
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Официальное название

Efficacy and Safety of Two Intravenous Tranexamic Acid Regimens Versus Placebo in Pediatric Idiopathic Scoliosis Surgery: A Randomized Double-Blind Trial

Обзор

This study will evaluate whether tranexamic acid (TXA), a medication used to reduce bleeding, is effective and safe in children undergoing surgery for idiopathic scoliosis. Significant blood loss is common during this type of surgery and often requires blood transfusions. Participants will be randomly assigned to one of three groups: (1) TXA given as an intravenous bolus followed by continuous infusion, (2) TXA given as two intravenous bolus doses, or (3) placebo (saline). Neither the patients nor the medical team will know which treatment is given. The main goal is to compare how much blood is lost during and after surgery and whether TXA reduces the need for blood transfusions. The study will also assess safety, including the risk of side effects such as seizures or blood clots. Patients will be followed for up to 30 days after surgery.

Подробное описание

Posterior spinal fusion for adolescent idiopathic scoliosis is associated with significant intraoperative blood loss and frequent need for blood transfusion. Tranexamic acid (TXA) is an antifibrinolytic agent that reduces bleeding, but optimal dosing strategies in pediatric scoliosis surgery remain unclear.

This study is a prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two intravenous TXA regimens compared with placebo in children undergoing surgical correction of idiopathic scoliosis.

Participants aged 10-18 years will be randomly assigned to receive either TXA or placebo during surgery. All patients will undergo standardized anesthesia, regional analgesia, and intraoperative neuromonitoring according to institutional protocols.

The primary objective is to assess the effect of TXA on perioperative blood loss. Secondary objectives include evaluation of transfusion requirements, laboratory parameters, and safety outcomes.

Patients will be followed for 30 days after surgery to assess postoperative outcomes and adverse events.

Вмешательства

  • Препарат Tranexamic Acid Bolus Plus Infusion
    Tranexamic acid administered intravenously as a 15 mg/kg bolus after induction of anesthesia, followed by continuous infusion at 1 mg/kg/h until the end of surgery.
  • Препарат Sodium Chloride 0.9% Inj
    Intravenous administration of 0.9% sodium chloride solution used as placebo, matched in volume and timing to the active comparator groups.
  • Препарат Tranexamic Acid Bolus Only
    Tranexamic acid administered intravenously as two bolus doses: 10 mg/kg after induction of anesthesia and 10 mg/kg 120 minutes after surgical incision or at the beginning of rod placement, whichever occurs first.

Первичные конечные точки

  • Total Blood Loss [Срок оценки: 24 hours postoperatively]
Вторичные конечные точки (9)
  • Total Volume of Blood Transfusion [Срок оценки: 24 hours postoperatively]
  • Hemoglobin Level [Срок оценки: immediately after surgery (0 hours)]
  • Hemoglobin Level [Срок оценки: 24 hours postoperatively]
  • Hematocrit Level [Срок оценки: immediately after surgery (0 hours)]
  • Hematocrit Level [Срок оценки: 24 hours postoperatively]
  • D-dimer Level [Срок оценки: 24 hours postoperatively]
  • Fibrinogen Level [Срок оценки: 24 hours postoperatively]
  • Prothrombin Time [Срок оценки: 24 hours postoperatively]
  • Activated Partial Thromboplastin Time [Срок оценки: 24 hours postoperatively]

Критерии участия

Критерии включения

  • Age 10 to 18 years
  • Diagnosis of idiopathic scoliosis requiring surgical correction (posterior spinal fusion)
  • American Society of Anesthesiologists (ASA) physical status I-II
  • Written informed consent from parents or legal guardians and assent from the child

Критерии исключения

  • Congenital or acquired coagulopathy
  • History of thromboembolic disease
  • History of seizures or epilepsy
  • Known hypersensitivity to tranexamic acid
  • Renal insufficiency (estimated glomerular filtration rate < 60 mL/min/1.73 m²)
  • Cardiac arrhythmias or cardiovascular disease requiring antiplatelet or anticoagulant therapy

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Польша · 1 центр
  • Poznan University of Medical Sciences — Poznan

Идентификаторы

NCT: NCT07581457 · 2/2026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗