Идёт набор NCT03687528

Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?

— Наблюдательное Head Injury Trauma Emergencies

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: CT-scanner.
Кому может быть актуально: Состояния в реестре: Head Injury Trauma, Emergencies. 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: Франция
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

Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?

Обзор

At the emergencies rooms, patients with head trauma meeting one of the NICE criteria, which include antiplatelet inhibitors treatment, are considered as patients with a risk of cerebral haemorrage and are taken systematically for a CT-scanner. However, there are more and more antiplatelet inhibitor's patient with minor head injury traumas seen at the emergencies room and the efficiency of this NICE criteria is controversial on litterature. This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

Подробное описание

Head injuries are a frequent reason for emergency services, and according to studies, they represent between 5% and 10% of patients treated in emergencies. Among them, 90% are minor head injury traumas. NICE criteria has been defined to establish patients who need a CT-scanner because of a risk of cerebral haemorrhage.

NICE criteria include several conditions including taking antiplatelet inhibitors. However, the real risk of cerebral haemorrhage for theses cases is controversial in litterature. In parallel, more and more patients undergoing antiplatelet inhibitor's treatment are seen in emergencies after a head injury trauma.

In routine protocol at the emergency rooms, these patients are seen for a clinical exam and next submitted to a CT-scanner. If the clinician can't detect a cerebral haemorrage, the patient will return at home.

This study aims to determine that the absence of no other NICE criteria than antiplatelet inhibitors treatment is a sufficient condition to eliminate a cerebral haemorrhage for patients with head injury traumas, and conversely, that antiplatelet inhibitors treatment would not be by itself an indication for a CT-scanner.

This is a diagnostic, case-only, prospective, multicenter study with a blinded primary outcome measure assessment.

As described in routine protocol, in this study antiplatelet inhibitor's patients with head injury trauma will be seen for a clinical exam and next submitted to a CT-scanner. After a month, patient will be called by the clinical center to ask about morbidity and mortality. Especially, clinicans will report on the emergence of a cerebral haemorrhage during this month.

Вмешательства

Лучевая терапия CT-scanner
After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.

Первичные конечные точки

Existence of a cerebral haemorrhage at the CT-scanner. [Срок оценки: 1 day]

Вторичные конечные точки (6)

Neurosurgeries' rate after one month [Срок оценки: 1 month]
Existence of a cerebral haemorrhage associated to death [Срок оценки: 1 month]
Existence of a cerebral haemorrhage associated to neurosurgery [Срок оценки: 1 month]
Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation [Срок оценки: 1 month]
Existence of a cerebral haemorrhage associated to more than 2 nights at hospital [Срок оценки: 1 month]
Death rate after one month [Срок оценки: 1 month]

Критерии участия

Критерии включения

At least 18 years old
Patient with a head injury trauma, described by the patient or seen at the clinical exam
Glasgow score between 13 and 15 at the clinical exam
Current treatment with antiplatelet inhibitors
Informed non opposition form signed