Observational Study of Cortical Spreading Depression in Human Brain Trauma (COSBID-TBI)

• ClinicalTrials.gov Identifier: NCT00803036
• Recruitment Status: Completed
• First Posted: December 5, 2008
• Last Update Posted: January 31, 2018
• Sponsor: University of Cincinnati
• Collaborators: University of Miami; University of Pittsburgh; Virginia Commonwealth University; King's College London
• Information provided by (Responsible Party): Jed Hartings, University of Cincinnati

Study Description

Brief Summary:

Since the primary damage from traumatic brain injury (TBI) is irreversible, the focus of medical management of TBI is preventing secondary injury that can be life-threatening and worsen patient outcome. Insight into the pathologic mechanisms of secondary injury, which are largely unknown, is required for developing better treatments.

In preliminary studies, the investigators have found that a pathologic brain activity, known as spreading depression, recurs in a large number of TBI patients in the first week after injury. Spreading depressions are short-circuits of brain function that arise spontaneously from an injury and spread repeatedly as waves into neighboring brain tissue. Animal research has shown that spreading depressions can cause secondary injury to the brain.

The primary objective of this observational study is to determine whether the occurrence or severity of spreading depression is related to worse neurologic recovery from TBI. Results from the study will determine whether monitoring of spreading depression should be used as a guide or target for improved medical management of the TBI patient.

Condition or disease
Traumatic Brain Injury

Study Design

• Study Type: Observational
• Actual Enrollment: 165 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
• Actual Study Start Date: January 2009
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2014

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Incidence of spreading depressions as assessed by continuous electrocorticography for 3-7 days after surgery. Primary neurologic outcome will be measured by the Glasgow Outcome Score - Extended. [ Time Frame: Six months post-TBI. ]

Secondary Outcome Measures :

1. Post-traumatic epilepsy questionnaire. [ Time Frame: 6, 12, and 24 months post-TBI ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.

Criteria

Inclusion Criteria:

• 18-80 years old
• diagnosis of TBI
• craniotomy performed as per required treatment of TBI
• craniotomy surgery < 7 days after TBI
• GCS<13 at time of decision for surgery
• expected neuromonitoring for >72 hr

Exclusion Criteria:

• any failure to meet above criteria
• pregnancy
• GCS 3 with fixed, dilated pupils

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33136

United States, Ohio

University of Cincinnati

Cincinnati, Ohio, United States, 45219

United States, Pennsylvania

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States, 15213

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

United Kingdom

King's College Hospital

London, United Kingdom, SE5 9RS

Sponsors and Collaborators

University of Cincinnati

University of Miami

University of Pittsburgh

Virginia Commonwealth University

King's College London

Investigators

• Principal Investigator: Jed A. Hartings, PhD; University of Cincinnati

More Information

Additional Information:

This study is conducted as a branch of COSBID, the Co-Operative Study of Brain Injury Depolarizations. 

• Responsible Party: Jed Hartings, Associate Research Professor, University of Cincinnati
• ClinicalTrials.gov Identifier: NCT00803036
• Other Study ID Numbers: 08-96-12-01; CDMRP-W81XWH-08-2-0016
• First Posted: December 5, 2008
• Last Update Posted: January 31, 2018
• Last Verified: January 2018

Keywords provided by Jed Hartings, University of Cincinnati:

spreading cortical depression; electroencephalography; traumatic brain injury; intensive care; vascular hypotension; intracranial hypertension

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Depression; Wounds and Injuries; Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System