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

Recruiting

• Conditions: Emergencies; Head Injury Trauma
• Interventions: Radiation: CT-scanner

• Registration Number: NCT03687528
• Lead Sponsor: Rennes University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2018-09-26
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Study Start: 2020-06-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3200

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with minor head injury trauma	CT-scanner	The emergency protocol for antiplatelet inhibitors treated patient with head injury trauma and meeting others NICE criteria involves a clinical exam followed by a CT-scanner.

Primary Outcome Measures

Name	Time	Method
Existence of a cerebral haemorrhage at the CT-scanner.	1 day	Cerebral haemorrhage seen at the CT-scanner.

Secondary Outcome Measures

Name	Time	Method
Existence of a cerebral haemorrhage associated to neurosurgery	1 month	Existence of a cerebral haemorrhage associated to neurosurgery
Existence of a cerebral haemorrhage associated to more than 2 nights at hospital	1 month	Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
Existence of a cerebral haemorrhage associated to death	1 month	Existence of a cerebral haemorrhage associated to death
Neurosurgeries' rate after one month	1 month	Neurosurgeries' rate after one month
Death rate after one month	1 month	Death rate after one month
Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation	1 month	Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation

Trial Locations

Locations (12)

CHU d'Angers; 🇫🇷 Angers, France

CHU Brest; 🇫🇷 Brest, France

CH Chartres; 🇫🇷 Chartres, France

CH Le Mans; 🇫🇷 Le Mans, France

CH Bretagne Sud, Lorient; 🇫🇷 Lorient, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU de Poitiers; 🇫🇷 Poitiers, France

CH Bretagne Sud - Quimperlé; 🇫🇷 Quimperlé, France

CHU de Rennes; 🇫🇷 Rennes, France

CH de Saint Brieuc; 🇫🇷 Saint-Brieuc, France

CH de Saint Malo; 🇫🇷 Saint-Malo, France

CH Bretagne Atlantique; 🇫🇷 Vannes, France