Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ? (TCAP)
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|ClinicalTrials.gov Identifier: NCT03687528|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : May 24, 2019
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.
|Condition or disease||Intervention/treatment|
|Head Injury Trauma Emergencies||Radiation: CT-scanner|
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 Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?|
|Estimated Study Start Date :||January 2, 2020|
|Estimated Primary Completion Date :||February 2, 2021|
|Estimated Study Completion Date :||February 28, 2021|
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.
After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.
- Existence of a cerebral haemorrhage at the CT-scanner. [ Time Frame: 1 day ]Cerebral haemorrhage seen at the CT-scanner.
- Neurosurgeries' rate after one month [ Time Frame: 1 month ]Neurosurgeries' rate after one month
- Existence of a cerebral haemorrhage associated to death [ Time Frame: 1 month ]Existence of a cerebral haemorrhage associated to death
- Existence of a cerebral haemorrhage associated to neurosurgery [ Time Frame: 1 month ]Existence of a cerebral haemorrhage associated to neurosurgery
- Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation [ Time Frame: 1 month ]Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation
- Existence of a cerebral haemorrhage associated to more than 2 nights at hospital [ Time Frame: 1 month ]Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
- Death rate after one month [ Time Frame: 1 month ]Death rate after one month
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687528
|Contact: Jérémie BONENFANT, Md||+33 2 99 28 43 firstname.lastname@example.org|
|Contact: Marie-Laure GERVAISemail@example.com|
|CHU d'Angers||Not yet recruiting|
|Contact: Pierre-Marie ROY, Pr +33241356650 firstname.lastname@example.org|
|CHU de Brest||Not yet recruiting|
|Contact: David GOETGHEBEUR, Md +33298347455 email@example.com|
|CH Le Mans||Not yet recruiting|
|Le Mans, France|
|Contact: Thibault SCHOTTE, Md +33243434343 firstname.lastname@example.org|
|CH de Lorient||Not yet recruiting|
|Contact: Nathalie DANIEL, Md +33297069090|
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|CHU de Rennes||Not yet recruiting|
|Rennes, France, 35033|
|Contact: CHU de Rennes 299284312 email@example.com|
|Principal Investigator: Jérémie BONENFANT, Md|
|Sub-Investigator: Jacques BOUGET, Pr|
|CH de Saint Brieuc||Not yet recruiting|
|Contact: Christian BRICE, Md +33296017489 firstname.lastname@example.org|
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|Contact: Mathieu PERENNES, Md +33297014141 email@example.com|
|Principal Investigator:||Jérémie BONENFANT, Md||Rennes University Hospital|