NCT05589103

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,692

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

October 21, 2022

Status Verified

October 1, 2022

Enrollment Period

2.9 years

First QC Date

October 17, 2022

Last Update Submit

October 17, 2022

Conditions

Keywords

Head Trauma InjuryHead TraumaTraumatic Intracranial HemorrhageAntiaggregants, Platelet

Outcome Measures

Primary Outcomes (1)

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

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.
  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'accueil des urgences - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial Hemorrhage, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 21, 2022

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

December 31, 2022

Last Updated

October 21, 2022

Record last verified: 2022-10

Locations