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Dynamic and Static Autoregulation After Brain Injury

This study has been completed.
Sponsor:
Information provided by:
Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier:
NCT01069250
First received: February 16, 2010
Last updated: NA
Last verified: March 2001
History: No changes posted
  Purpose

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.


Condition Intervention
Acute Brain Injuries
TBI (Traumatic Brain Injury)
Intracranial Hemorrhages
 Other: There are no interventions in this study

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Disturbed cerebrovascular autoregulation after brain injury [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: August 2001
Study Completion Date: February 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Brain injury
Patients after traumatic brain injury or spontaneous intracranial bleeding
 Other: There are no interventions in this study

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069250

Locations
Germany
University Medical Center of the Johannes Gutenberg-University Mainz
Mainz, Germany, 55131
Sponsors and Collaborators
Johannes Gutenberg University Mainz
  More Information

No publications provided

Responsible Party: Kristin Engelhard, PhD, MD, Department of Anesthesiology
ClinicalTrials.gov Identifier: NCT01069250     History of Changes
Other Study ID Numbers: 2001 448/01, 01
Study First Received: February 16, 2010
Last Updated: February 16, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by Johannes Gutenberg University Mainz:
dynamic cerebrovascular autoregulation
static cerebrovascular autoregulation
acute brain injury
transcranial Doppler ultrasound
critical care

Additional relevant MeSH terms:
Hemorrhage
Brain Injuries
Intracranial Hemorrhages
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013