Viewing Study NCT06173427



Ignite Creation Date: 2024-05-06 @ 7:53 PM
Last Modification Date: 2024-10-26 @ 3:16 PM
Study NCT ID: NCT06173427
Status: RECRUITING
Last Update Posted: 2023-12-15
First Post: 2022-11-03

Brief Title: Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD
Sponsor: University Hospital Strasbourg France
Organization: University Hospital Strasbourg France

Study Overview

Official Title: Monitoring of Intracranial Hemorrhage in Non-severe Head Trauma Patients Hospitalized in the UHCD Indication of a Control Imaging
Status: RECRUITING
Status Verified Date: 2023-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: Head-Trauma
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 patients 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None