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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03687528
Acronym
TCAP
Enrollment
3200
Registered
2018-09-27
Start date
2020-06-15
Completion date
2026-12-31
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Head Injury Trauma

Keywords

emergencies, platelet inhibitors, minor head injury trauma, CT-scan

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 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.

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.

Interventions

RADIATIONCT-scanner

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

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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 * Patients with double anti-platelet aggregation * Patients on anticoagulants

Design outcomes

Primary

MeasureTime frameDescription
Existence of a cerebral haemorrhage at the CT-scanner.1 dayCerebral haemorrhage seen at the CT-scanner.

Secondary

MeasureTime frameDescription
Existence of a cerebral haemorrhage associated to death1 monthExistence of a cerebral haemorrhage associated to death
Existence of a cerebral haemorrhage associated to neurosurgery1 monthExistence of a cerebral haemorrhage associated to neurosurgery
Neurosurgeries' rate after one month1 monthNeurosurgeries' rate after one month
Existence of a cerebral haemorrhage associated to more than 2 nights at hospital1 monthExistence of a cerebral haemorrhage associated to more than 2 nights at hospital
Death rate after one month1 monthDeath rate after one month
Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation1 monthExistence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation

Countries

France

Contacts

Primary ContactPaul-Georges REUTER, Pr
paul-georges.reuter@chu-rennes.fr+33 2 99 28 43 21
Backup ContactMarie-Laure GERVAIS
marie-laure.gervais@chu-rennes.fr0299284312

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026