NCT04428970

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
214

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2020

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

10.8 years

First QC Date

June 6, 2020

Last Update Submit

January 23, 2021

Conditions

Traumatic Brain Injury

Keywords

Intracranial pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Complications

    Intervention-related complications

    up to 30 days

Secondary Outcomes (1)

  • Clinical outcome

    up to 30 days

Study Arms (1)

TBI patients with ICP monitoring

Patients with severe TBI (GCS\<9 on arrival) receiving invasive ICP monitoring

Procedure: Invasive ICP monitoring

Interventions

Invasive ICP monitoringPROCEDURE

Insertion of a parenchymal pressure measuring probe

TBI patients with ICP monitoring

Eligibility Criteria

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

Patients transferred to our department after severe TBI who had received invasive ICP monitoring will be included in this study.

You may qualify if:

  • Severe Traumatic Brain Injury (GCS\<9 on arrival)
  • Implantation of invasive intracranial parenchymal ICP monitoring

You may not qualify if:

  • incomplete data records

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Universtiy of Vienna

Vienna, A-1090, Austria

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D.

Study Record Dates

First Submitted

June 6, 2020

First Posted

June 11, 2020

Study Start

January 1, 2007

Primary Completion

September 30, 2017

Study Completion

January 31, 2020

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)