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Идёт набор NCT06062888

FFP In Traumatic BRAin INjury (FIT-BRAIN) Trial

Фаза II / Фаза III С лечением Moderate to Severe Traumatic Brain Injury

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: Fresh Frozen Plasma (FFP).
Кому может быть актуально
Состояния в реестре: Moderate to Severe Traumatic Brain Injury. Базовые параметры: 18 лет — 65 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

Multi-institutional Phase 2/3 Trial of Fresh Frozen Plasma (FFP) in Patients With Moderate to Severe Traumatic Brain Injury (TBI)

Обзор

The goal of this clinical trial is to learn about treatment with fresh frozen plasma (FFP) in individuals with moderate to severe traumatic brain injury. The two main question\[s\]it aims to answer are: * Is the FFP treatment safe? * Does the FFP treatment impact the 24-hour, 3-month and 6-month outcomes, intensive-care free days, mortality, and hospital brain and physical function at discharge. Patients with moderate to severe TBI will randomly receive either: * Standard of care treatment * Standard of care treatment + 2 units of FFP. Researchers will compare participants receiving standard of care treatment to those receiving experimental fresh frozen plasma (FFP) treatment to see if the FFP is safe and beneficial to participant outcomes.

Подробное описание

The two units of fresh frozen plasma will consist of 400-500 ml. The 24-hour, 3-month and 6-month outcome measures include hemorrhagic progression of contusion (HPC) measured on 24-hour follow-up CT scan, the Disability Rating Score (DRS), 24-hour Glasgow Coma Scale (GCS) and the 3-month and 6-month Extended Glasgow Outcome Score (GOS-E).

A third sub aim of the trial is to establish peripheral blood biomarkers, and radiographic features on the initial cross- sectional imaging, that could identify the optimal target population and predict the response to treatment.

Вмешательства

  • Биопрепарат Fresh Frozen Plasma (FFP)
    Standard of Care + 2 units (400-500 ml) of fresh frozen plasma

Первичные конечные точки

  • Extended Glasgow Outcome Scale (GOS-E) [Срок оценки: 3 months]
Вторичные конечные точки (2)
  • Hemorrhagic progression of the contusion (HPC) [Срок оценки: The first 24 hour post-injury]
  • Disability Rating Scale (DRS) [Срок оценки: Discharge or day 7 of the hospital stay and 3 months post-injury]

Критерии участия

Критерии включения

  • Male or female between the ages of 18 and 65 years
  • Moderate to severe TBI: GCS 3-12
  • Cerebral trauma confirmed on the initial CT scan with radiographic findings consistent with Brain Injury Guidelines category 3 (BIG 3).
  • The potential participant's wallet, when present, was examined and no power of attorney related to blood product administration was identified.

Критерии исключения

  • Persons with a known history of adverse reaction to plasma products.
  • Persons with a known history of congestive heart failure, renal failure, liver failure, or severe respiratory dysfunction requiring home use of supplemental oxygen.
  • Persons who are currently incarcerated.
  • Persons with inadequate venous access.
  • Treatment cannot start within 1 hour of arrival at the hospital.
  • The time of injury is unknown.
  • Non-survivable injuries in the estimation of the attending trauma and/or neurosurgeon.
  • Interfacility transfers
  • Class 3 hemorrhagic shock
  • Persons with known "do not resuscitate" orders prior to randomization
  • Persons who refuse the administration of blood products
  • Persons with a research "opt out" bracelet
  • Persons who require FFP for any other indication (e.g., reversal of coagulopathy)

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 · 1 центр
  • Northwestern University — Chicago

Публикации

  • Liggett MR, Lashley S, Gill NP, Scholtens DM, Dawood ZS, Alam HB. Plasma therapy for traumatic brain injury: Rationale for a prospective randomized trial. Transfusion. 2024 Jul;64(7):1362-1371. doi: 10.1111/trf.17928. Epub 2024 Jun 28. No abstract available. PMID 38940059
  • Joseph B, Obaid O, Dultz L, Black G, Campbell M, Berndtson AE, Costantini T, Kerwin A, Skarupa D, Burruss S, Delgado L, Gomez M, Mederos DR, Winfield R, Cullinane D; AAST BIG Multi-institutional Study Group. Validating the Brain Injury Guidelines: Results of an American Association for the Surgery of Trauma prospective multi-institutional trial. J Trauma Acute Care Surg. 2022 Aug 1;93(2):157-165. PMID 35343931
  • Jin G, Liggett MR, Ho JW, Dawood ZS, Chtraklin K, Diaz D, Alam HB. Plasma treatment is associated with decreased brain lesion and resuscitation requirements after traumatic brain injury in a swine model of prolonged damage-control resuscitation. J Trauma Acute Care Surg. 2024 Dec 1;97(6):954-960. doi: 10.1097/TA.0000000000004457. Epub 2024 Oct 15. PMID 39733294

Идентификаторы

NCT: NCT06062888 · PR212312 · CDMRP-W81XWH2211106

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗