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

NCT04993495 | Unknown

• 1 other identifier: 49RC21_0140
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

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

  Day 30

Secondary Outcomes (3)

• loss of one point on the rankin scale

  Day 30

• number of cerebral computerized tomography scan

  Day 30

• time spent in emergencies

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients admitted to the emergency department for minor head injury

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

DOUILLET Delphine

Angers, France

RECRUITING

Central Study Contacts

Delphine DOUILLET

CONTACT

0241356650; delphine.douillet@chu-angers.fr

DRCI Promotion Interne

CONTACT

0241353637; DRCI-Promotion-Interne@chu-angers.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: August 6, 2021
• Study Start: July 7, 2022
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: August 26, 2022

Record last verified: 2022-07

Locations

FR (1)