Dynamic and Static Autoregulation After Brain Injury

August 21, 2013 updated by: Patrick Schramm, Johannes Gutenberg University Mainz

Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

16

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mainz, Germany, 55131
        • University Medical Center of the Johannes Gutenberg-University Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Brain injury
Patients after traumatic brain injury or spontaneous intracranial bleeding
Other: There are no interventions in this study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disturbed cerebrovascular autoregulation after brain injury
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

February 16, 2010

First Submitted That Met QC Criteria

February 16, 2010

First Posted (Estimate)

February 17, 2010

Study Record Updates

Last Update Posted (Estimate)

August 22, 2013

Last Update Submitted That Met QC Criteria

August 21, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2001 448/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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