Clinical trial NCT00803036: Observational Study of Cortical Spreading Depression in Human Brain Trauma
Official title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Traumatic Brain Injury
Keywords: spreading cortical depression
electroencephalography
traumatic brain injury
intensive care
vascular hypotension
intracranial hypertension
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: University of Miami
name: University of Pittsburgh
name: Virginia Commonwealth University
name: King's College London
First posted: 2008-12-05
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.

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.


Eligibility 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

Primary outcomes:
measure: 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.
timeFrame: Six months post-TBI.
Secondary outcomes:
measure: Post-traumatic epilepsy questionnaire.
timeFrame: 6, 12, and 24 months post-TBI
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: London
country: United Kingdom
facility: King's College Hospital
Study officials:
affiliation: University of Cincinnati
name: Jed A. Hartings, PhD
role: PRINCIPAL_INVESTIGATOR
References: