ClinicalTrials.gg
Status unknownNCT05589103Trauma-HeadUpdated Oct 21, 2022

Mild Head Trauma in the Emergency Room: Assessment of the Risk of Intracranial Hemorrhage in Patients Receving Platelet Inhibitors.

An observational study in Head Trauma Injury, sponsored by University Hospital, Strasbourg, France. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-21.

Sponsored by University Hospital, Strasbourg, France · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
1,692
Ages
18 Years and older
Sex
All
01

Study summary

The clinical signs presented by a patient with a mild head injury are highly variable but remain strongly predictive of brain damage. The reference examination for the diagnosis of post-traumatic intracranial hemorrhage is currently the cerebral scanner without injection of contrast medium. Magnetic resonance imaging (MRI) tends to surpass CT in equipped centers, except for suspected bone lesions. The time required to perform brain imaging depends on the patient's clinical condition, comorbidities and treatments.

The responsibility of antiplatelet agents in post-traumatic intracranial hemorrhage is currently discussed, particularly with aspirin.

The hypothesis is that there is no significant difference in the proportion of intracranial hemorrhage in patients on antiplatelet agents after mild head trauma, in the absence of other factors favoring the occurrence of intracranial hemorrhage.

02

Conditions studied

  • Head Trauma Injury

Browse trials for

Keywords

  • Head Trauma Injury
  • Head Trauma
  • Traumatic Intracranial Hemorrhage
  • Antiaggregants, Platelet
03

In context

Craniocerebral Trauma

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

This study's planned enrollment of 1,692 is above the median of 200 across 115 observational studies indexed under Craniocerebral Trauma.

Browse Craniocerebral Trauma studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 994 studies on the registry; 353 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Adult patient (≥18 years old) victim of mild head trauma visiting the emergency room of the Strasbourg University Hospital during 2017.

Eligibility criteria

Inclusion criteria

  • Adult patient (≥18 years old)
  • Visit to the emergency room of the Strasbourg University Hospital during 2017
  • Victim of mild head trauma
  • Patient who has given their consent to the reuse of their data for the purposes of this research.

Non-inclusion criteria

  • Patient who expressed their opposition to participating in the study
  • Subject under safeguard of justice
  • Subject under guardianship or curatorship
  • Patient on anticoagulant
  • Non-isolated head trauma (AVP, fall greater than 6 meters, etc.)
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
1,692 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Propensity score on the factors influencing the taking of antiplatelet agents.

    Time frame: Files analysed retrospectively from January 01, 2017 to December 31, 2017 will be examined

07

Study locations

1 of 1 sites recruiting
  • Service d'accueil des urgences - CHU de Strasbourg - France
    Strasbourg, 67091, France
    • Florent BAICRY, MD · Contact · florent.baicry@chru-strasbourg.fr · 33 3 69 55 03 86
    • Florent BAICRY, MD · Principal investigator
    • Quentin DELLENBACH, MD · Sub investigator
    • Pierrick LE BORGNE, MD · Sub investigator
    • Pascal BILBAULT, MD, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05589103
Responsible party
Sponsor
First posted
Oct 21, 2022
Start date
Jan 1, 2020
Primary completion
Dec 2022 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Oct 21, 2022

Study contacts

Florent BAICRY, MD
Contact
florent.baicry@chru-strasbourg.fr
33 3 69 55 03 86

Oversight

Data monitoring committee
No
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 Oct 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion