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

NCT ID: NCT04993495

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 470 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-07
• Study Completion Date: 2023-07-07

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.

Conditions

Head Injury Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

DOUILLET Delphine

Angers, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Delphine DOUILLET

Role: CONTACT

delphine.douillet@chu-angers.fr

0241356650 ext. +33

DRCI Promotion Interne

Role: CONTACT

DRCI-Promotion-Interne@chu-angers.fr

0241353637 ext. +33

Facility Contacts

Delphine DOUILLET, MD

Role: primary

delphine.douillet@chu-angers.fr

Other Identifiers

49RC21_0140

Identifier Type: -

Identifier Source: org_study_id