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Status unknownNCT04993495TCLUpdated Aug 26, 2022

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

An observational study in Head Injury Trauma, sponsored by University Hospital, Angers. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-26.

Sponsored by University Hospital, Angers · Observational

The sponsor has not verified this record recently (last verified Jul 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
470
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Head Injury Trauma
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In context

Craniocerebral Trauma

253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.

This study's planned enrollment of 470 is above the median of 180 across 108 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

University Hospital, Angers is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients admitted to the emergency department for minor head injury

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
470 participants (estimated)
Patient registry
No
06

What researchers measure

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

    Time frame: Day 30

Secondary outcomes

  1. loss of one point on the rankin scale

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

    Time frame: Day 30

  2. number of cerebral computerized tomography scan

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

    Time frame: Day 30

  3. time spent in emergencies

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

    Time frame: Day 1

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04993495
Lead sponsor
University Hospital, Angers
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Jul 7, 2022
Primary completion
Jul 7, 2023 (estimated)
Completion
Jul 7, 2023 (estimated)
Last update
Aug 26, 2022

Study contacts

Delphine DOUILLET
Contact
delphine.douillet@chu-angers.fr
0241356650 ext. +33
DRCI Promotion Interne
Contact
DRCI-Promotion-Interne@chu-angers.fr
0241353637 ext. +33

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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