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Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma

NCT04993495 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 470

Last updated 2022-08-26

No results posted yet for this study

Summary

Head injuries are a common reason for consultation in emergency departments. The clinical severity of head injury is assessed using the Glasgow Coma Scale (GCS). Between 71% and 97.5% of patients with head trauma seen in the emergency department are considered minor, that is to say with an initial GCS 13 and the consequences are quite variable. Three to 10% of patients will have short, medium or long-term health consequences. According to the studies, there are between 2.1 and 8% of intracranial bleeding immediate or delayed (up to one month), with about 1% of them, the need to resort to neurosurgery.

Following a minor head trauma, it is recommended, in the absence of clinical signs of severity, to realize a brain scan (cerebral computerized tomography scan (CT scan): reference imaging examination) within 6h (between 4 hours and 8 hours according to studies), a hospital surveillance of 24h, with the realization of a control scanner within 12 hours to 24 hours in case of treatment by anticoagulants or antiaggregation.

In December 2015, Journal of the American Medical Association published an article evaluating two clinical algorithms across the Atlantic, the New Orleans Criteria (NOC) and the Canadian CT Head Rule, to identify a group of patients with a very low risk of severe brain damage.

The performance of this score is unquestionably, however, it does not include patients treated with antiplatelet or anticoagulant drugs; risk factors having a decisive impact on the incidence of intracranial bleeding.

In this context, various studies have been carried out retrospectively in Angers to assess the incidence and risk factors of the occurrence of an immediate or delayed intracerebral hemorrhage in patients with minor head trauma with or without anti-thrombotic treatment.

Conditions

  • Head Injury Trauma

Sponsors & Collaborators

  • University Hospital, Angers

    lead OTHER_GOV

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2023-07-07
Completion
2023-07-07

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04993495 on ClinicalTrials.gov