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Идёт набор NCT05364749

Selective CT for Anticoagulated Head Injured Patients

— Наблюдательное Head Injury Traumatic Brain Injury Intracranial Hemorrhage, Traumatic Blunt Head 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
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Head Injury, Traumatic Brain Injury, Intracranial Hemorrhage, Traumatic, Blunt Head Injury. Базовые параметры: от 16 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
Канада
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

Selective Neuroimaging for Head-injured Emergency Patients Who Take Anticoagulant Medication

Обзор

The goal is to derive and a clinical decision rule for safe exclusion of traumatic brain injury without neuroimaging in head-injured ED patients who take anticoagulant medications. The objectives are to: 1. Derive and externally validate a new highly sensitive and maximally specific clinical decision rule for the exclusion of traumatic brain injury in head-injured ED patients who take anticoagulant medications; and, 2. Estimate the sensitivity and specificity of existing head injury clinical decision rules in head-injured ED patients who take anticoagulant medications.

Подробное описание

This is a prospective cohort study enrolling 4000 anticoagulated patients presenting with blunt head trauma to the emergency department. Emergency physicians will record the presence or absence of clinical predictors for traumatic brain injury at the time of assessment. All patients will undergo head CT scanning and are followed for 30 days.

The adjudicated primary outcome is clinically important traumatic brain injury diagnosed at the index ED presentation. The secondary outcome is delayed clinically important traumatic brain injury, diagnosed within 30 days of normal index head CT scan.

The primary analysis will be to derive a novel clinical decision rule which excludes clinically important traumatic brain injury diagnosed at the index ED visit. The secondary analyses will include:

1. The diagnostic accuracy of existing head injury clinical decision rules in diagnosing clinically important traumatic brain injury on index ED visit, in patients who take anticoagulation; and, 2. The sensitivity and specificity of the new and existing rules for the diagnosis of both index and delayed clinically important traumatic brain injury.

Первичные конечные точки

  • Clinically important traumatic brain injury [Срок оценки: Index emergency department presentation]
Вторичные конечные точки (1)
  • Delayed clinically important traumatic brain injury [Срок оценки: Diagnosed within 30 days of a negative index head CT scan at the index emergency department presentation]

Критерии участия

Критерии включения

  • Age ≥16 years
  • Presents to the emergency department after a head injury
  • Patient has a head CT in the emergency department
  • Is a current anticoagulant user

Критерии исключения

  • Head injury occurred >48 h before patient's arrival to the emergency department
  • Penetrating head injury
  • Previously enrolled
  • Patient resides outside of the hospital's catchment area
  • Patient was transferred from another emergency department following neuroimaging
  • Patient was not managed by the emergency or trauma physician in the emergency department
  • Leaves the emergency department prior to completion of their medical assessment

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

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 7 центров
  • University of British Columbia — Vancouver
  • Hamilton Health Sciences Corporation — Hamilton
  • Kingston Health Sciences Centre — Kingston
  • Ottawa Hospital Research Institute — Ottawa
  • Sinai Health — Toronto
  • Hôpital du Sacré-Cœur de Montréal — Montreal
  • CHU de Québec - Université Laval — Québec

Идентификаторы

NCT: NCT05364749 · 202104PJ2-461744

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗