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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04993495
Acronym
TCL
Enrollment
470
Registered
2021-08-06
Start date
2022-07-07
Completion date
2023-07-07
Last updated
2022-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head Injury Trauma

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.

Interventions

None listed

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
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 30to assess stratification score performance to predict the occurrence of acute intracranial bleeding in patients with minor head injury

Secondary

MeasureTime frameDescription
loss of one point on the rankin scaleDay 30Performance assessment of hemorrhagic risk stratification score to predict severe intracerebral hemorrhage
number of cerebral computerized tomography scanDay 30Assessment of the potential reduction in the number of scanners if the score had been applied.
time spent in emergenciesDay 1Retrospective assessment of the potential impact of applying the score on the length of time spent in emergencies

Countries

France

Contacts

Primary ContactDelphine DOUILLET
delphine.douillet@chu-angers.fr0241356650
Backup ContactDRCI Promotion Interne
DRCI-Promotion-Interne@chu-angers.fr0241353637

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026