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NCT04428970 Clinical Trial

Intracranial Pressure (ICP) Monitoring Following Traumatic Brain Injury (TBI)

Traumatic Brain Injury Clinical Trial

Official title:
Intracranial Pressure Monitoring Following Traumatic Brain Injury - Evaluation of Indications, Complications, and Significance of Follow-up Imaging.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04428970
Other study ID # 2086/2019
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2007
Est. completion date January 31, 2020

Study information
Verified date January 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of this retrospective cohort study is to evaluate complications rates, indications, and the utility of follow-up imaging studies of ICP measurement in severe TBI patients.

Recruitment information / eligibility
Status Completed
Enrollment 214
Est. completion date January 31, 2020
Est. primary completion date September 30, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Severe Traumatic Brain Injury (GCS<9 on arrival) - Implantation of invasive intracranial parenchymal ICP monitoring Exclusion Criteria: - incomplete data records

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Invasive ICP monitoring
Insertion of a parenchymal pressure measuring probe

Locations
Country Name City State
Austria Medical Universtiy of Vienna Vienna

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complications Intervention-related complications up to 30 days
Secondary Clinical outcome Outcome at discharge measured by the Glasgow Outcome Scale (GOS), range 1(death) - 5 (good recovery) up to 30 days
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