Traumatic Brain InjuryCOSBID-TBINCT00803036
Observational Study of Cortical Spreading Depression in Human Brain Trauma
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 165 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2009to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.
Who may be able to join
- 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
Who cannot join
- any failure to meet above criteria
- pregnancy
- GCS 3 with fixed, dilated pupils
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
University of Cincinnati
Cincinnati, Ohio, 45219
University of Miami
Miami, Florida, 33136
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
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.
- Conditions
- Traumatic Brain Injury
- Keywords
- spreading cortical depression, electroencephalography, traumatic brain injury, intensive care, vascular hypotension, intracranial hypertension
- Medical subject headings
- Brain Injuries, Traumatic, Hypotension, Intracranial Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months post-TBI.
Secondary outcomes (1)
Post-traumatic epilepsy questionnaire.
Measured: 6, 12, and 24 months post-TBI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, University of Pittsburgh, Virginia Commonwealth University, King's College London
- Responsible party
- Principal investigator, Jed Hartings, University of Cincinnati
- Investigators
- Jed A. Hartings, PhD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00803036
- Sponsor's protocol ID
- 08-96-12-01
- Other IDs
- CDMRP-W81XWH-08-2-0016
- Acronym
- COSBID-TBI
- Status last verified
- Jan 2018
- First submitted
- 4 Dec 2008
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spreading Depressions as Secondary Insults After Traumatic Injury to the Human Brain
- ClinicalTrials.gov ID
- NCT00803036
- Acronym / sponsor ID
- COSBID-TBI / 08-96-12-01
- Conditions
- Traumatic Brain Injury
- Keywords
- spreading cortical depression, electroencephalography, traumatic brain injury, intensive care, vascular hypotension, intracranial hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- University of CincinnatiUniversity, hospital or other
- Collaborators
- University of Miami, University of Pittsburgh, Virginia Commonwealth University, King's College London
- Study start
- Jan 2009 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 5 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to study hospitals who require neurosurgery for acute traumatic brain injury.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- any failure to meet above criteria
- pregnancy
- GCS 3 with fixed, dilated pupils
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Post-traumatic epilepsy questionnaire.
Time frame: 6, 12, and 24 months post-TBI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- This study is conducted as a branch of COSBID, the Co-Operative Study of Brain Injury Depolarizations.Link provided by the sponsor.
Related trials for Traumatic Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jed A. Hartings, PhD principal investigator
University of Cincinnati
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury, run by University of Cincinnati at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Six months post-TBI.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.