Clinical trial NCT04993495: Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma
Official title: Prospective Observational Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head Injury Trauma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-08-06
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients admitted to the emergency department for minor head injury

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.


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.

Primary outcomes:
measure: intracranial hemorrhage rate in patients in patients considered to be low risk according to the score created by hospital of Angers (negative predictive value).
timeFrame: Day 30
Secondary outcomes:
measure: loss of one point on the rankin scale
timeFrame: Day 30
measure: number of cerebral computerized tomography scan
timeFrame: Day 30
measure: time spent in emergencies
timeFrame: Day 1
Other outcomes:
Locations:
city: Angers
country: France
facility: DOUILLET Delphine
Study officials:
References: