Head Injury TraumaTCAPNCT03687528
Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting NICE Criteria : is the CT-scan Mandatory ?
An observational study of Head Injury Trauma and Emergencies, run by Rennes University Hospital at 12 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head Injury Trauma, Emergencies
- What is being tested?
- CT-scanner
- Type of treatment
- Surgery or procedure
- How many people
- 3,200 participants
- Where
- 12 sitesFrance
- Study dates
- 15 Jun 2020to Dec 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Absence of CT-scanner
- Patients with double anti-platelet aggregation
- Patients on anticoagulants
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
France12 sites, 12 recruiting
- Recruiting
CHU d'Angers
Angers
Pierre-Marie ROY, Pr
Delphine DOUILLET
- Recruiting
CHU Brest
Brest
Jerome Ducrocq
Jerôme DUCROCQ
- Recruiting
CH Chartres
Chartres
Paul BACHELIER, Md
Paul BACHELIER
- Recruiting
CH Le Mans
Le Mans
Benjamin WINTENBERGER, Md
Benjamin WINTENBERGER
- Recruiting
CH Bretagne Sud, Lorient
Lorient
Nathalie DANIEL, Md
Thomas LE NORMAND
- Recruiting
CHU de Nantes
Nantes
Emmanuel MONTASSIER, Md
Emmanuel MONTASSIER
- Recruiting
CHU de Poitiers
Poitiers
Jeremy GUENEZAN
Jeremy GUENEZAN
- Recruiting
CH Bretagne Sud - Quimperlé
Quimperlé
Camille LARUE, Md
Camille LARUE, Md
- Recruiting
CHU de Rennes
Rennes, 35033
CHU de Rennes, 299284312, marie-laure.gervais@chu-rennes.fr
Jérémie BONENFANT, Md
- Not yet recruiting
CH de Saint Brieuc
Saint-Brieuc
Christian BRICE, Md, +33296017489, christian.brice@ch-stbrieuc.fr
- Recruiting
CH de Saint Malo
St-Malo
Sabrina PERNET, Md
Sabrina PERNET
- Not yet recruiting
CH Bretagne Atlantique
Vannes
Claire Broche-Valence
Claire BROCHE-VALENCE
About this study
Official title: 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.
Read the 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.
- Conditions
- Head Injury Trauma, Emergencies
- Being tested
- CT-scanner
- Keywords
- emergencies, platelet inhibitors, minor head injury trauma, CT-scan
- Medical subject headings
- Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-scannerRadiation
After a clinical exam, patient have a CT-scanner to check any cerebral haemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: CT-scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Existence of a cerebral haemorrhage at the CT-scanner.
Cerebral haemorrhage seen at the CT-scanner.
Measured: 1 day
Secondary outcomes (6)
Neurosurgeries' rate after one month
Neurosurgeries' rate after one month
Measured: 1 month
Existence of a cerebral haemorrhage associated to death
Existence of a cerebral haemorrhage associated to death
Measured: 1 month
Existence of a cerebral haemorrhage associated to neurosurgery
Existence of a cerebral haemorrhage associated to neurosurgery
Measured: 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
Measured: 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
Measured: 1 month
Death rate after one month
Death rate after one month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start15 Jun 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injury TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paul-Georges REUTER, Pr, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687528
- Sponsor's protocol ID
- 35RC17_8839_T.CAP
- Acronym
- TCAP
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2018
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided