Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD

Head Trauma Clinical Trial

— Head-Trauma  

Official title:

Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD. Indication of a Control Imaging ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173427
• Other study ID #: 7492
• Status: Recruiting
• Start date: November 1, 2019
• Est. completion date: December 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Florent BAICRY, MD
• Phone: 33 3 88 12 86 82
• Email: florent.baicry[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion 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)

• 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

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Craniocerebral Trauma
• Head Trauma
• Hemorrhage
• Intracranial Hemorrhages
• Wounds and Injuries

Locations

Country	Name	City	State
France	Service d'accueil des urgences - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective description of clinical evolution of post-traumatic intracerebral hemorrhages		Through study completion, an average of 4 months