Dynamic and Static Autoregulation After Brain Injury | NCT01069250

Studies
Dynamic and Static Autoregulation After Brain Injury

NCT01069250

Sponsor

Johannes Gutenberg University Mainz

Status

Completed

Last Update Posted

Aug 22, 2013Estimated

Enrollment

16Actual

Phase

Not provided

Conditions

Acute Brain Injuries
TBI (Traumatic Brain Injury)
Intracranial Hemorrhages

Interventions

There are no interventions in this study

Countries

Germany

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

Aug 2013

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

Aug 2001

Primary Completion Date

Dec 2009Actual

Completion Date

Feb 2010Actual

First Submitted Date

Feb 16, 2010

First Submission Date that Met QC Criteria

Feb 16, 2010

First Posted Date

Feb 17, 2010Estimated

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

Aug 21, 2013

Last Update Posted Date

Aug 22, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Patrick Schramm, Patrick Schramm, MD, Johannes Gutenberg University MainzPrincipal Investigator

Lead Sponsor

Johannes Gutenberg University MainzOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The aim of the study assesses static and dynamic cerebrovascular autoregulation daily over one week in patients with traumatic brain injury or intracranial hemorrhage to quantify the temporal profile of the autoregulatory status.

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

Not provided

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

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Brain injury		Patients after traumatic brain injury or spontaneous intracranial bleeding	Other: There are no interventions in this study

Interventions

Name	Type	Description	Arm Group Labels	Other Names
There are no interventions in this study	Other		Brain injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disturbed cerebrovascular autoregulation after brain injury		7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Traumatic brain injury
Intracranial hemorrhage

Exclusion Criteria:

Measurement of TCD were impossible
Injury of the legs (if the both tigh cuffs for dynamic autoregulation could not be fixed)

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 after traumatic brain injury or intracranial bleeding wich had a Glasgow-Coma-Scale (GCS) of less than 8 and were initially sedated, intubated and mechanically ventilated.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center of the Johannes Gutenberg-University Mainz		Mainz		55131	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21252706	Result	Schramm P, Klein KU, Pape M, Berres M, Werner C, Kochs E, Engelhard K. Serial measurement of static and dynamic cerebrovascular autoregulation after brain injury. J Neurosurg Anesthesiol. 2011 Jan;23(1):41-4. doi: 10.1097/ANA.0b013e3181f35854.

ID	Term
D001930	Brain Injuries
D000070642	Brain Injuries, Traumatic
D020300	Intracranial Hemorrhages

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma