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

Emergencies Clinical Trial

— TCAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03687528
• Other study ID #: 35RC17_8839_T.CAP
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Rennes University Hospital
• Contact: Jérémie BONENFANT, Md
• Phone: +33 2 99 28 43 21
• Email: jeremie.bonenfant[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Emergencies
• Head Injury Trauma
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Existence of a cerebral haemorrhage at the CT-scanner.	Cerebral haemorrhage seen at the CT-scanner.	1 day
Secondary	Neurosurgeries' rate after one month	Neurosurgeries' rate after one month	1 month
Secondary	Existence of a cerebral haemorrhage associated to death	Existence of a cerebral haemorrhage associated to death	1 month
Secondary	Existence of a cerebral haemorrhage associated to neurosurgery	Existence of a cerebral haemorrhage associated to neurosurgery	1 month
Secondary	Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation	Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation	1 month
Secondary	Existence of a cerebral haemorrhage associated to more than 2 nights at hospital	Existence of a cerebral haemorrhage associated to more than 2 nights at hospital	1 month
Secondary	Death rate after one month	Death rate after one month	1 month