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

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ClinicalTrials.gov Identifier: NCT03687528
Recruitment Status : Not yet recruiting
First Posted : September 27, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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.


Condition or disease Intervention/treatment
Head Injury Trauma Emergencies Radiation: 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.


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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?
Estimated Study Start Date : January 2, 2019
Estimated Primary Completion Date : February 2, 2021
Estimated Study Completion Date : February 28, 2021


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




Primary Outcome Measures :
  1. Existence of a cerebral haemorrhage at the CT-scanner. [ Time Frame: 1 day ]
    Cerebral haemorrhage seen at the CT-scanner.


Secondary Outcome Measures :
  1. Neurosurgeries' rate after one month [ Time Frame: 1 month ]
    Neurosurgeries' rate after one month

  2. Existence of a cerebral haemorrhage associated to death [ Time Frame: 1 month ]
    Existence of a cerebral haemorrhage associated to death

  3. Existence of a cerebral haemorrhage associated to neurosurgery [ Time Frame: 1 month ]
    Existence of a cerebral haemorrhage associated to neurosurgery

  4. 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

  5. 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

  6. Death rate after one month [ Time Frame: 1 month ]
    Death rate after one month



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03687528


Contacts
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Contact: Jérémie BONENFANT, Md +33 2 99 28 43 21 jeremie.bonenfant@chu-rennes.fr
Contact: Marie-Laure GERVAIS 0299284312 marie-laure.gervais@chu-rennes.fr

Locations
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France
CHU d'Angers Not yet recruiting
Angers, France
Contact: Pierre-Marie ROY, Pr    +33241356650    pmroy@chu-angers.fr   
CHU de Brest Not yet recruiting
Brest, France
Contact: David GOETGHEBEUR, Md    +33298347455    david.goetghebeur@chu-brest.fr   
CH Le Mans Not yet recruiting
Le Mans, France
Contact: Thibault SCHOTTE, Md    +33243434343    tschotte@ch-lemans.fr   
CH de Lorient Not yet recruiting
Lorient, France
Contact: Nathalie DANIEL, Md    +33297069090      
CHU de Nantes Not yet recruiting
Nantes, France
Contact: Emmanuel MONTASSIER, Md    +33240083934    emmanuel.montassier@chu-nantes.fr   
CHU de Poitiers Not yet recruiting
Poitiers, France
Contact: Olivier MIMOZ, Pr    +33549444600    o.mimoz@chu-poitiers.fr   
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: CHU de Rennes    299284312    marie-laure.gervais@chu-rennes.fr   
Principal Investigator: Jérémie BONENFANT, Md         
Sub-Investigator: Jacques BOUGET, Pr         
CH de Saint Brieuc Not yet recruiting
Saint-Brieuc, France
Contact: Christian BRICE, Md    +33296017489    christian.brice@ch-stbrieuc.fr   
CH de Saint Malo Not yet recruiting
Saint-Malo, France
Contact: Sabrina PERNET, Md    +33299212121    s.pernet@ch-stmalo.fr   
CHU de Tours Not yet recruiting
Tours, France
Contact: Said LARIBI, Pr    +33247478109    s.laribi@chu-tours.fr   
CH de Vannes Not yet recruiting
Vannes, France
Contact: Mathieu PERENNES, Md    +33297014141    mathieu.perennes@ch-bretagne-atlantique.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Jérémie BONENFANT, Md Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03687528     History of Changes
Other Study ID Numbers: 35RC17_8839_T.CAP
First Posted: September 27, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
emergencies
platelet inhibitors
minor head injury trauma
CT-scan

Additional relevant MeSH terms:
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Wounds and Injuries
Emergencies
Craniocerebral Trauma
Disease Attributes
Pathologic Processes
Trauma, Nervous System
Nervous System Diseases
Platelet Aggregation Inhibitors