NCT06173427

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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Longer than P75 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2019

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 15, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

4.1 years

First QC Date

November 3, 2022

Last Update Submit

December 13, 2023

Conditions

Keywords

Head TraumaIntracranial hemorrhageCerebral hemorrhagic lesionsNeurological monitoringBrain scan

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

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaIntracranial Hemorrhages

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

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

Locations