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

Last updated: December 23, 2024
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Brain Injury

Treatment

CT-scanner

Clinical Study ID

NCT03687528
35RC17_8839_T.CAP
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria :

  • Absence of CT-scanner

  • Patients with double anti-platelet aggregation

  • Patients on anticoagulants

Study Design

Total Participants: 3200
Treatment Group(s): 1
Primary Treatment: CT-scanner
Phase:
Study Start date:
June 15, 2020
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • CHU d'Angers

    Angers,
    France

    Active - Recruiting

  • CHU Brest

    Brest,
    France

    Active - Recruiting

  • CH Chartres

    Chartres,
    France

    Active - Recruiting

  • CH Le Mans

    Le Mans,
    France

    Active - Recruiting

  • CH Bretagne Sud, Lorient

    Lorient,
    France

    Active - Recruiting

  • CHU de Nantes

    Nantes,
    France

    Active - Recruiting

  • CHU de Poitiers

    Poitiers,
    France

    Active - Recruiting

  • CH Bretagne Sud - Quimperlé

    Quimperlé,
    France

    Active - Recruiting

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CH de Saint Brieuc

    Saint-Brieuc,
    France

    Site Not Available

  • CH de Saint Malo

    Saint-Malo,
    France

    Active - Recruiting

  • CHU de Tours

    Tours,
    France

    Site Not Available

  • CH Bretagne Atlantique

    Vannes,
    France

    Site Not Available

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