Status:
COMPLETED
Observational Study of Cortical Spreading Depression in Human Brain Trauma
Lead Sponsor:
University of Cincinnati
Collaborating Sponsors:
University of Miami
University of Pittsburgh
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-80 years
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 outcom...
Eligibility Criteria
Inclusion
- 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
- any failure to meet above criteria
- pregnancy
- GCS 3 with fixed, dilated pupils
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00803036
Start Date
January 1 2009
End Date
September 1 2014
Last Update
January 31 2018
Active Locations (5)
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1
University of Miami
Miami, Florida, United States, 33136
2
University of Cincinnati
Cincinnati, Ohio, United States, 45219
3
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
4
Virginia Commonwealth University
Richmond, Virginia, United States, 23298