- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03687528
Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ? (TCAP)
Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Angers, France
- Recruiting
- CHU d'Angers
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Brest, France
- Recruiting
- CHU Brest
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Chartres, France
- Recruiting
- CH Chartres
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Le Mans, France
- Recruiting
- CH Le Mans
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Lorient, France
- Recruiting
- CH Bretagne Sud, Lorient
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Nantes, France
- Recruiting
- CHU de Nantes
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Poitiers, France
- Recruiting
- CHU De Poitiers
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Quimperlé, France
- Recruiting
- CH Bretagne Sud - Quimperlé
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Rennes, France, 35033
- Recruiting
- Chu de Rennes
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Saint-Brieuc, France
- Not yet recruiting
- CH de Saint Brieuc
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Saint-Malo, France
- Recruiting
- CH de Saint Malo
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Vannes, France
- Not yet recruiting
- CH Bretagne Atlantique
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Major patients undergoing antiplatelet inhibitors treatment which are reported at the clinical exam as having a head injury trauma.
These patients don't meet another NICE criteria :
- neurological focal deficit
- amnesia for more than 30 min
- glasgow score less than 15 after 2 hours
- loss of consciousness associated with either a high velocity or an age > 65 years old
- suspicion of a cranial open fracture
- fracture on cranial basis
- more than 1 vomit
- post-traumatic convulsion
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
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After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Existence of a cerebral haemorrhage at the CT-scanner.
Time Frame: 1 day
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Cerebral haemorrhage seen at the CT-scanner.
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1 day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurosurgeries' rate after one month
Time Frame: 1 month
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Neurosurgeries' rate after one month
|
1 month
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Existence of a cerebral haemorrhage associated to death
Time Frame: 1 month
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Existence of a cerebral haemorrhage associated to death
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1 month
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Existence of a cerebral haemorrhage associated to neurosurgery
Time Frame: 1 month
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Existence of a cerebral haemorrhage associated to neurosurgery
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1 month
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Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation
Time Frame: 1 month
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Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation
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1 month
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Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
Time Frame: 1 month
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Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
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1 month
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Death rate after one month
Time Frame: 1 month
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Death rate after one month
|
1 month
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC17_8839_T.CAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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