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Идёт набор NCT02880163

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Без фазы С лечением Hemorrhagic Shock Trauma Exsanguinating Hemorrhage Shock; Traumatic

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: ResQFoam.
Кому может быть актуально
Состояния в реестре: Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic. Базовые параметры: от 15 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
США
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

Reducing Exsanguination Via In-Vivo Expandable Foam

Обзор

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.

Вмешательства

  • Устройство ResQFoam
    Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma

Первичные конечные точки

  • Change in systolic blood pressure after deployment of ResQFoam over baseline value [Срок оценки: All SBP assessments prior to deployment of IP through removal of IP and completion of laparotomy. Patient will be followed through hospital discharge or through Day 30, whichever comes first.]

Критерии участия

Критерии включения

  • Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
  • Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
  • Class III or IV hemorrhagic shock or
  • Assessment of Blood Consumption (ABC) score ≥ 2
  • Confirmation of abdominal hemorrhage by:
  • Direct visualization or
  • Positive Focused Assessment with Sonography in Trauma (FAST) or
  • Diagnostic Peritoneal Aspiration (DPA)
  • No other known, uncontrolled active sources of hemorrhage
  • Subject is intubated and sedated per local guidelines
  • Decision to administer foam is made within 30 minutes of admission to the emergency department.
  • Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
  • Definitive surgical care is expected to occur within three hours of foam deployment
  • Subject must also be receiving concurrent transfusion of fluids or blood products.

Критерии исключения

  • Known or suspected major diaphragm injury
  • Known or suspected untreated pneumothorax
  • Known or suspected untreated hemothorax
  • Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
  • Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
  • Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
  • Patients with Pulseless Electrical Activity
  • Known allergy to isocyanate
  • Known or suspected pregnancy
  • History of prior abdominal surgery or evidence of abdominal surgery (scars)
  • Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
  • Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
  • Known Prisoners
  • Subjects with burns > 20% of total body surface area
  • Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
  • Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
  • Known enrollment in another randomized, interventional study

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 2 центра
  • University of Alabama at Birmingham — Birmingham
  • University of Cincinnati — Cincinnati

Публикации

  • Maegele M. Effective approaches to address noncompressible torso hemorrhage. Curr Opin Crit Care. 2024 Jun 1;30(3):202-208. doi: 10.1097/MCC.0000000000001141. Epub 2024 Feb 28. PMID 38441108

Идентификаторы

NCT: NCT02880163 · CLIN-030

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗