Intracranial Pressure (ICP) Monitoring Following Traumati... | NCT04428970

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

NCT04428970

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Jan 26, 2021Actual

Enrollment

214Actual

Phase

Not provided

Conditions

Traumatic Brain Injury

Interventions

Invasive ICP monitoring

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2007Actual

Primary Completion Date

Sep 30, 2017Actual

Completion Date

Jan 31, 2020Actual

First Submitted Date

Jun 6, 2020

First Submission Date that Met QC Criteria

Jun 9, 2020

First Posted Date

Jun 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 23, 2021

Last Update Posted Date

Jan 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

214Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TBI patients with ICP monitoring		Patients with severe TBI (GCS<9 on arrival) receiving invasive ICP monitoring	Procedure: Invasive ICP monitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Invasive ICP monitoring	Procedure	Insertion of a parenchymal pressure measuring probe	TBI patients with ICP monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications	Intervention-related complications	up to 30 days

Secondary Outcomes

Measure	Description	Time Frame
Clinical outcome	Outcome at discharge measured by the Glasgow Outcome Scale (GOS), range 1(death) - 5 (good recovery)	up to 30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

incomplete data records

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Universtiy of Vienna		Vienna		A-1090	Austria

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided