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Идёт набор NCT06414031

Tranexamic Acid for Reduction of Transfusion in Abdominal Surgery

Фаза III С лечением Surgical Blood Loss Transfusion-dependent Anemia Abdomen Disease

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, Placebo.
Кому может быть актуально
Состояния в реестре: Surgical Blood Loss, Transfusion-dependent Anemia, Abdomen Disease. Базовые параметры: от 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
Германия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Tranexamic Acid for Reduction of Intra- and Postoperative Transfusion Requirements in Elective Abdominal Surgery: Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if the administration of tranexamic acid can reduce the necessity of blood transfusions in adult patients undergoing major abdominal surgery. . It will also inform about safety of tranexamic acid in this setting. The main question it aims to answer is: Does tranexamic acid lower the probability of receiving at least one blood transfusion during or after surgery? Participants will compare tranexamic acid o a placebo (a look-alike substance that contains no drug) to see if tranexamic acid works to reduce the necessity of a blood transfusion.

Вмешательства

  • Препарат Tranexamic Acid
    Intravenous administration
  • Препарат Placebo
    Intravenous administration

Первичные конечные точки

  • Transfusion necessity [Срок оценки: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
Вторичные конечные точки (8)
  • Transfusion amount [Срок оценки: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
  • Blood loss [Срок оценки: From skin incision to suture]
  • Postoperative complications and mortality [Срок оценки: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
  • Length of hospital stay [Срок оценки: From hospital admission to discharge]
  • Operation time [Срок оценки: From skin incision to suture]
  • Anesthesia time [Срок оценки: From anesthesia induction to end of anesthesia]
  • D-dimer levels [Срок оценки: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]
  • Adverse events [Срок оценки: Until hospital discharge or 30 days postoperatively, whatever occurs earlier]

Критерии участия

Критерии включения

  • Age 18 years or above
  • Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy
  • Adequate renal function with serum creatinine <250 µmol/L (2.82 mg/dL)
  • Written informed consent obtained before randomization
  • Negative pregnancy test for women of childbearing potential within 14 days of commencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of <1% per year when used consistently and correctly, such as intravaginal and transdermal combined (oestrogen and progestogen containing) hormonal contraception, injectable and implantable progestogen-only hormonal contraception, intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).

Критерии исключения

  • Severe anaemia, defined as a haemoglobin concentration <8 g/dL (<5 mmol/L) or anaemia with haemoglobin concentration ≥8 to <10 g/dL (≥5,0 to <6,2 mmol/l) and one or several of the following symptoms suggesting hypoxemia:
  • Clinical signs of tachycardia, e.g., resting heart rate >100 beats/minute, palpitation etc.
  • Clinical signs of hypotension, e.g., resting systolic blood pressure <100 mmHg, orthostatic dysregulation etc.
  • Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate >20 breaths/min.
  • Thrombocytopenia with platelets <60 x 109 /L
  • Confirmed bleeding disorder with the need for specific preventive perioperative treatment (e.g., factor deficiency with the need of perioperative substitution)
  • A priori refusal of blood transfusions
  • Confirmed thrombophilia with a pertinent need for perioperative anticoagulation
  • Allergy / hypersensitivity to tranexamic acid
  • Recent (<30 days) thromboembolic event
  • History of medically confirmed convulsions
  • In female subjects: pregnancy or lactation

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

Германия · 2 центра
  • University Hospital Carl Gustav Carus Dresden — Dresden
  • University Hospital, Dpt. of Abdominal, Vascular and Endocrine Surgery — Halle

Публикации

  • Ronellenfitsch U, Kestel A, Klose J, Rebelo A, Bucher M, Ebert D, Mikolajczyk R, Wienke A, Kegel T, Hering J, Haiduk C, Richter M, Steighardt J, Grohmann E, Otto L, Kleeff J. Tranexamic Acid for reduction of intra- and postoperative TRansfusion requirements in elective Abdominal surgery (TATRA): study protocol for an investigator-initiated, multicenter, double-blind, placebo-controlled, randomized PMID 39425234

Идентификаторы

NCT: NCT06414031 · TATRA · 01KG2305 · 2023-509970-43-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗