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NCT01069250 Clinical Trial

Dynamic and Static Autoregulation After Brain Injury

Intracranial Hemorrhages Clinical Trial

Official title:
Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01069250
Other study ID # 2001 448/01
Secondary ID
Status Completed
Phase N/A
First received February 16, 2010
Last updated August 21, 2013
Start date August 2001
Est. completion date February 2010

Study information
Verified date August 2013
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date February 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• There are no interventions in this study

Locations
Country Name City State
Germany University Medical Center of the Johannes Gutenberg-University Mainz Mainz

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Disturbed cerebrovascular autoregulation after brain injury 7 days No
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