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

NCT03687528 | Recruiting

• 1 other identifier: 35RC17_8839_T.CAP
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 12

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.

Conditions

Head Injury Trauma; Emergencies

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Existence of a cerebral haemorrhage at the CT-scanner.

  Cerebral haemorrhage seen at the CT-scanner.

  1 day

Secondary Outcomes (6)

• Neurosurgeries' rate after one month

  1 month

• Existence of a cerebral haemorrhage associated to death

  1 month

• Existence of a cerebral haemorrhage associated to neurosurgery

  1 month

• Existence of a cerebral haemorrhage associated to hospitalization with more than 24h of intubation

  1 month

• Existence of a cerebral haemorrhage associated to more than 2 nights at hospital

  1 month

Study Arms (1)

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.

Radiation: CT-scanner

Interventions

CT-scanner RADIATION

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

Patient with minor head injury trauma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Absence of CT-scanner
• Patients with double anti-platelet aggregation
• Patients on anticoagulants

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (12)

CHU d'Angers

Angers, France

RECRUITING

CHU Brest

Brest, France

RECRUITING

CH Chartres

Chartres, France

RECRUITING

CH Le Mans

Le Mans, France

RECRUITING

CH Bretagne Sud, Lorient

Lorient, France

RECRUITING

CHU de Nantes

Nantes, France

RECRUITING

CHU de Poitiers

Poitiers, France

RECRUITING

CH Bretagne Sud - Quimperlé

Quimperlé, France

RECRUITING

CHU de Rennes

Rennes, 35033, France

RECRUITING

CH de Saint Brieuc

Saint-Brieuc, France

NOT YET RECRUITING

CH de Saint Malo

St-Malo, France

RECRUITING

CH Bretagne Atlantique

Vannes, France

NOT YET RECRUITING

MeSH Terms

Conditions

Emergencies

Interventions

Tomography Scanners, X-Ray Computed

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Paul-Georges REUTER, Pr

  CHU Rennes

  STUDY DIRECTOR

Central Study Contacts

Paul-Georges REUTER, Pr

CONTACT

+33 2 99 28 43 21; paul-georges.reuter@chu-rennes.fr

Marie-Laure GERVAIS

CONTACT

0299284312; marie-laure.gervais@chu-rennes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: September 27, 2018
• Study Start: June 15, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (12)