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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2010 by University of Cincinnati.
Recruitment status was:  Recruiting
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Information provided by:
University of Cincinnati Identifier:
First received: December 4, 2008
Last updated: November 8, 2010
Last verified: November 2010

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.

Traumatic Brain Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain

Resource links provided by NLM:

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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:
  • Post-traumatic epilepsy questionnaire. [ Time Frame: 6, 12, and 24 months post-TBI ]

Estimated Enrollment: 180
Study Start Date: January 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00803036

Contact: Jed A. Hartings, PhD 513-558-3567

United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Ross Bullock, MD, PhD    305-243-4456   
United States, Ohio
University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jed A Hartings, PhD    513-295-2370   
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: David O. Okonkwo, MD, PhD    412-647-2772   
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Bruce Mathern, MD    804-828-9165   
United Kingdom
King's College Hospital Recruiting
London, United Kingdom, SE5 9RS
Contact: Clemens Pahl, DM    44-7930-697838   
Sponsors and Collaborators
University of Cincinnati
University of Miami
University of Pittsburgh
Virginia Commonwealth University
King's College London
Principal Investigator: Jed A. Hartings, PhD University of Cincinnati
  More Information

Additional Information:
Responsible Party: Jed A. Hartings, PhD, University of Cincinnati Identifier: NCT00803036     History of Changes
Other Study ID Numbers: 08-96-12-01
Study First Received: December 4, 2008
Last Updated: November 8, 2010

Keywords provided by University of Cincinnati:
spreading cortical depression
traumatic brain injury
intensive care
vascular hypotension
intracranial hypertension

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Behavioral Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System processed this record on March 24, 2017