Ignite Creation Date:
2024-05-06 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 12:55 PM
Study NCT ID:
NCT03687528
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2018-09-26
Brief Title:
Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria is the CT-scan Mandatory
Sponsor:
Rennes University Hospital
Organization:
Rennes University Hospital
Study Overview
Official Title:
Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage NICE Criteria is the CT-scan Mandatory
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCAP
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 inhibitors 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
However there are more and more antiplatelet inhibitors 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 inhibitors 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 cant 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 inhibitors 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
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 inhibitors 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 cant 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 inhibitors 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None