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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head Injury Trauma

• Study Type: Observational
• Enrollment (Anticipated): 470

Contacts and Locations

• Study Contact: Name: Delphine DOUILLET; Phone Number: +33 0241356650; Email: delphine.douillet@chu-angers.fr

Study Locations

• France
  • Angers, France
    • Recruiting
    • DOUILLET Delphine
    • Contact: Delphine DOUILLET, MD; Email: delphine.douillet@chu-angers.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients admitted to the emergency department for minor head injury

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
loss of one point on the rankin scale	Performance assessment of hemorrhagic risk stratification score to predict severe intracerebral hemorrhage	Day 30
number of cerebral computerized tomography scan	Assessment of the potential reduction in the number of scanners if the score had been applied.	Day 30
time spent in emergencies	Retrospective assessment of the potential impact of applying the score on the length of time spent in emergencies	Day 1

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Anticipated): July 7, 2023
• Study Completion (Anticipated): July 7, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Craniocerebral Trauma
• Other Study ID Numbers: 49RC21_0140

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No