Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD
Head-Trauma
1 other identifier
observational
180
1 country
1
Brief Summary
The non-neurosurgical management of post-traumatic cerebral hemorrhagic lesions is currently poorly codified. It consists of neurological monitoring for 24 to 48 hours, and the performance of an almost systematic brain scan. Anti-aggregation and anticoagulation treatments are stopped for 14 to 28 days and should be resumed according to the risk-benefit ratio and the advice of the patient's treating physicians and cardiologists. If the bleeding lesions do not progress, the patients are allowed to return home. If the lesions progress, the patients remain hospitalized for further monitoring, a new brain scan and neurosurgical advice. This study seeks to show that the performance of systematic brain imaging in the absence of clinical deterioration of patients admitted to the UHCD for post-traumatic intracranial hemorrhage could be avoided, and thus to administer an unnecessary dose of irradiation to the patients, and would also have a significant financial stake. Several recent studies have shown that there is no need to perform a follow-up brain scan in the absence of neurological deterioration, even in anticoagulated patients or those on antiplatelet drugs. Despite the growing number of articles, no recommendation or consensus has been proposed.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2019
Longer than P75 for all trials
1 active site
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
November 1, 2019
CompletedFirst Submitted
Initial submission to the registry
November 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedFirst Posted
Study publicly available on registry
December 15, 2023
CompletedDecember 15, 2023
December 1, 2023
4.1 years
November 3, 2022
December 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Retrospective description of clinical evolution of post-traumatic intracerebral hemorrhages
Through study completion, an average of 4 months
Eligibility Criteria
Adult patient (≥18 years old) admitted to Emergency department of the Strasbourg University Hospital during the year 2017 (from 01/01/2017 to 31/12/2017)
You may qualify if:
- Adult patient (≥18 years old)
- Admitted to Emergency department of the Strasbourg University Hospital during the year 2017 (from 01/01/2017 to 31/12/2017)
- Patient having given his consent to the reuse of his data for the purpose of this research
- Hospitalized at the University Hospital for monitoring of a post-traumatic intracranial hemorrhage
You may not qualify if:
- Patient having expressed opposition to participate in the study
- Non-isolated cranial trauma (MVA, fall greater than 6 meters ..)
- Subject under court protection
- Subject under guardianship or curatorship
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Service d'accueil des urgences - CHU de Strasbourg - France
Strasbourg, 67091, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
November 3, 2022
First Posted
December 15, 2023
Study Start
November 1, 2019
Primary Completion
December 1, 2023
Study Completion
December 1, 2023
Last Updated
December 15, 2023
Record last verified: 2023-12