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Clinical Trials/NCT04993495
NCT04993495
Unknown
Not Applicable

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

University Hospital, Angers1 site in 1 country470 target enrollmentJuly 7, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head Injury Trauma
Sponsor
University Hospital, Angers
Enrollment
470
Locations
1
Primary Endpoint
intracranial hemorrhage rate in patients in patients considered to be low risk according to the score created by hospital of Angers (negative predictive value).
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 7, 2022
End Date
July 7, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Angers
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • patient \> 18 years old
  • head injury
  • Glasgow Coma Scale \> or = 13

Exclusion Criteria

  • Refusal of participation,
  • Indication of a scanner for a reason other than minor head injury
  • follow-up not possible
  • pregnant woman or breastfeeding
  • patients in life-threatening emergency situations.

Outcomes

Primary Outcomes

intracranial hemorrhage rate in patients in patients considered to be low risk according to the score created by hospital of Angers (negative predictive value).

Time Frame: Day 30

to assess stratification score performance to predict the occurrence of acute intracranial bleeding in patients with minor head injury

Secondary Outcomes

  • loss of one point on the rankin scale(Day 30)
  • number of cerebral computerized tomography scan(Day 30)
  • time spent in emergencies(Day 1)

Study Sites (1)

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