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

ConditionsHead Injury TraumaEmergencies
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRennes University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absence of CT-scanner

Patients with double anti-platelet aggregation

Patients on anticoagulants

Trial 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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • CT-scanner

    Radiation

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

Treatment groups

3,200 Participants
are divided into 1 treatment group
Group A: Patient with minor head injury trauma1 intervention

Trial outcomes

Primary outcomes

1

Existence of a cerebral haemorrhage at the CT-scanner.

Cerebral haemorrhage seen at the CT-scanner.

Time frame
1 day

Secondary outcomes

1

Neurosurgeries' rate after one month

Neurosurgeries' rate after one month

Time frame
1 month
2

Existence of a cerebral haemorrhage associated to death

Existence of a cerebral haemorrhage associated to death

Time frame
1 month
3

Existence of a cerebral haemorrhage associated to neurosurgery

Existence of a cerebral haemorrhage associated to neurosurgery

Time frame
1 month
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rennes University Hospital

Lead sponsor

Source ClinicalTrials.gov
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