An observational study in Head Injury Trauma and Emergencies, sponsored by Rennes University Hospital. Recruiting at 12 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by Rennes University Hospital · Observational
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.
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.
1,694 studies on the registry are indexed under Emergencies; 332 are open to participants now.
This study's planned enrollment of 3,200 is above the median of 350 across 715 observational studies indexed under Emergencies.
Browse Emergencies studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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 :
Exclusion Criteria :
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.
Radiation: 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.
Cerebral haemorrhage seen at the CT-scanner.
Time frame: 1 day
Neurosurgeries' rate after one month
Neurosurgeries' rate after one month
Time frame: 1 month
Existence of a cerebral haemorrhage associated to death
Existence of a cerebral haemorrhage associated to death
Time frame: 1 month
Existence of a cerebral haemorrhage associated to neurosurgery
Existence of a cerebral haemorrhage associated to neurosurgery
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 hospitalization with more than 24h of intubation
Time frame: 1 month
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
Time frame: 1 month
Death rate after one month
Death rate after one month
Time frame: 1 month
Plan to share: Undecided
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Rennes University Hospital