Dynamic and Static Autoregulation After Brain Injury

• Sponsor: Johannes Gutenberg University Mainz (Other)
• Overall Status: Completed
• CT.gov ID: NCT01069250
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Duration (Months): 102
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Brain Injuries; TBI (Traumatic Brain Injury); Intracranial Hemorrhages	Other: There are no interventions in this study

Study Design

• Study Type: Observational
• Actual Enrollment: 16 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Serial Measurement of Static and Dynamic Cerebrovascular Autoregulation After Brain Injury
• Study Start Date: Aug 1, 2001
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Feb 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Disturbed cerebrovascular autoregulation after brain injury [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	University Medical Center of the Johannes Gutenberg-University Mainz	Mainz		Germany	55131

Sponsors and Collaborators

• Johannes Gutenberg University Mainz

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Patrick Schramm, Patrick Schramm, MD, Johannes Gutenberg University Mainz
• ClinicalTrials.gov Identifier: NCT01069250
• Other Study ID Numbers: 2001 448/01
• First Posted: Feb 17, 2010
• Last Update Posted: Aug 22, 2013
• Last Verified: Aug 1, 2013

• Keywords provided by Patrick Schramm, Patrick Schramm, MD, 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; Intracranial Hemorrhages; Hemorrhage; Wounds and Injuries

Study Results

No Results Posted as of Aug 22, 2013