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NCT Number: NCT03687528

Platelet Inhibitor Treated Patients With Head Injury Trauma Meeting 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Patients with double anti-platelet aggregation
  • Patients on anticoagulants

Treatment and study plan

CT-scanner

Radiation

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

Primary outcomes

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

    Time frame: 1 day

    Cerebral haemorrhage seen at the CT-scanner.

Secondary outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Laure GERVAIS

CONTACT

[email protected]

0299284312

Paul-Georges REUTER, Pr

CONTACT

[email protected]

+33 2 99 28 43 21

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Platelet Inhibitor Treated Patients With Head Injury Trauma Without Any Clinical Symptoms of Cerebral Haemorrhage (NICE Criteria) : is the CT-scan Mandatory ?

Acronym: TCAP

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Sep 27, 2018
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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