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

Sponsor
University Hospital, Angers (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04993495
Collaborator
(none)
470
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    470 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prospective Observational Study Evaluating the Potential Impact of a Hemorrhagic Risk Stratification Score in Patients With Mild Head Trauma
    Anticipated Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2022
    Anticipated Study Completion Date :
    Sep 1, 2022

    Outcome Measures

    Primary Outcome Measures

    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). [Day 30]

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

    Secondary Outcome Measures

    1. loss of one point on the rankin scale [Day 30]

      Performance assessment of hemorrhagic risk stratification score to predict severe intracerebral hemorrhage

    2. number of cerebral computerized tomography scan [Day 30]

      Assessment of the potential reduction in the number of scanners if the score had been applied.

    3. time spent in emergencies [Day 1]

      Retrospective assessment of the potential impact of applying the score on the length of time spent in emergencies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • University Hospital, Angers

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Angers
    ClinicalTrials.gov Identifier:
    NCT04993495
    Other Study ID Numbers:
    • 49RC21_0140
    First Posted:
    Aug 6, 2021
    Last Update Posted:
    Aug 6, 2021
    Last Verified:
    Apr 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 6, 2021