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

NCT ID: NCT03687528

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-15

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Head Injury Trauma Emergencies

Keywords

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emergencies platelet inhibitors minor head injury trauma CT-scan

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient with minor head injury trauma

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.

CT-scanner

Intervention Type RADIATION

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

Interventions

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CT-scanner

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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul-Georges REUTER, Pr

Role: STUDY_DIRECTOR

CHU Rennes

Locations

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CHU d'Angers

Angers, , France

Site Status RECRUITING

CHU Brest

Brest, , France

Site Status RECRUITING

CH Chartres

Chartres, , France

Site Status RECRUITING

CH Le Mans

Le Mans, , France

Site Status RECRUITING

CH Bretagne Sud, Lorient

Lorient, , France

Site Status RECRUITING

CHU de Nantes

Nantes, , France

Site Status RECRUITING

CHU de Poitiers

Poitiers, , France

Site Status RECRUITING

CH Bretagne Sud - Quimperlé

Quimperlé, , France

Site Status RECRUITING

CHU de Rennes

Rennes, , France

Site Status RECRUITING

CH de Saint Brieuc

Saint-Brieuc, , France

Site Status NOT_YET_RECRUITING

CH de Saint Malo

St-Malo, , France

Site Status RECRUITING

CH Bretagne Atlantique

Vannes, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Paul-Georges REUTER, Pr

Role: CONTACT

Phone: +33 2 99 28 43 21

Email: [email protected]

Marie-Laure GERVAIS

Role: CONTACT

Phone: 0299284312

Email: [email protected]

Facility Contacts

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Pierre-Marie ROY, Pr

Role: primary

Delphine DOUILLET

Role: backup

Jerome Ducrocq

Role: primary

Jerôme DUCROCQ

Role: backup

Paul BACHELIER, Md

Role: primary

Paul BACHELIER

Role: backup

Benjamin WINTENBERGER, Md

Role: primary

Benjamin WINTENBERGER

Role: backup

Nathalie DANIEL, Md

Role: primary

Thomas LE NORMAND

Role: backup

Camille LARUE

Role: backup

Emmanuel MONTASSIER, Md

Role: primary

Emmanuel MONTASSIER

Role: backup

Jeremy GUENEZAN

Role: primary

Camille LARUE, Md

Role: primary

CHU de Rennes

Role: primary

Jérémie BONENFANT, Md

Role: backup

Jacques BOUGET, Pr

Role: backup

Christian BRICE, Md

Role: primary

Sabrina PERNET, Md

Role: primary

Sabrina PERNET

Role: backup

Claire Broche-Valence

Role: primary

Other Identifiers

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35RC17_8839_T.CAP

Identifier Type: -

Identifier Source: org_study_id