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

March 28, 2023 updated by: Rennes University Hospital

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

Recruiting

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

Observational

Enrollment (Anticipated)

3200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Angers, France
        • Recruiting
        • CHU d'Angers
      • Brest, France
        • Recruiting
        • CHU Brest
      • Chartres, France
        • Recruiting
        • CH Chartres
      • Le Mans, France
        • Recruiting
        • CH Le Mans
      • Lorient, France
        • Recruiting
        • CH Bretagne Sud, Lorient
      • Nantes, France
        • Recruiting
        • CHU de Nantes
      • Poitiers, France
        • Recruiting
        • CHU De Poitiers
      • Quimperlé, France
        • Recruiting
        • CH Bretagne Sud - Quimperlé
      • Rennes, France, 35033
        • Recruiting
        • Chu de Rennes
      • Saint-Brieuc, France
        • Not yet recruiting
        • CH de Saint Brieuc
      • Saint-Malo, France
        • Recruiting
        • CH de Saint Malo
      • Vannes, France
        • Not yet recruiting
        • CH Bretagne Atlantique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
Cerebral haemorrhage seen at the CT-scanner.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurosurgeries' rate after one month
Time Frame: 1 month
Neurosurgeries' rate after one month
1 month
Existence of a cerebral haemorrhage associated to death
Time Frame: 1 month
Existence of a cerebral haemorrhage associated to death
1 month
Existence of a cerebral haemorrhage associated to neurosurgery
Time Frame: 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
Time Frame: 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
Time Frame: 1 month
Existence of a cerebral haemorrhage associated to more than 2 nights at hospital
1 month
Death rate after one month
Time Frame: 1 month
Death rate after one month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2020

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

September 26, 2018

First Posted (Actual)

September 27, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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