|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of Cincinnati |
|---|---|
| Collaborators: |
University of Miami University of Pittsburgh Virginia Commonwealth University King's College London |
| Information provided by: | University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00803036 |
Purpose
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 |
|---|
|
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 |
| 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) |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jed A. Hartings, PhD | 513-558-3567 | jed.hartings@uc.edu |
| United States, Florida | |
| University of Miami | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Ross Bullock, MD, PhD 305-243-4456 RBullock@med.miami.edu | |
| United States, Ohio | |
| University of Cincinnati | Recruiting |
| Cincinnati, Ohio, United States, 45219 | |
| Contact: Jed A Hartings, PhD 513-295-2370 jed.hartings@uc.edu | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: David O. Okonkwo, MD, PhD 412-647-2772 okonkwodo@upmc.edu | |
| United States, Virginia | |
| Virginia Commonwealth University | Recruiting |
| Richmond, Virginia, United States, 23298 | |
| Contact: Bruce Mathern, MD 804-828-9165 bmathern@mcvh-vcu.edu | |
| United Kingdom | |
| King's College Hospital | Recruiting |
| London, United Kingdom, SE5 9RS | |
| Contact: Clemens Pahl, DM 44-7930-697838 clemenspahl@doctors.org.uk | |
| Principal Investigator: | Jed A. Hartings, PhD | University of Cincinnati |
More Information
| Responsible Party: | Jed A. Hartings, PhD, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT00803036 History of Changes |
| Other Study ID Numbers: | 08-96-12-01, CDMRP-W81XWH-08-2-0016 |
| Study First Received: | December 4, 2008 |
| Last Updated: | November 8, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
spreading cortical depression electroencephalography traumatic brain injury |
intensive care vascular hypotension intracranial hypertension |
|
Depression Depressive Disorder Brain Injuries Behavioral Symptoms Mood Disorders Mental Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |