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Dynamic and Static Autoregulation After Brain Injury

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069250
First Posted: February 17, 2010
Last Update Posted: August 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Patrick Schramm, Johannes Gutenberg University Mainz
  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

Further study details as provided by Patrick Schramm, Johannes Gutenberg University Mainz:

Primary Outcome Measures:
  • Disturbed cerebrovascular autoregulation after brain injury [ Time Frame: 7 days ]

Enrollment: 16
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069250


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

Publications:
Responsible Party: Patrick Schramm, Patrick Schramm, MD, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT01069250     History of Changes
Other Study ID Numbers: 2001 448/01
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: August 22, 2013
Last Verified: August 2013

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

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