Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00505908
Status:
COMPLETED
Last Update Posted:
2020-03-16
First Post:
2007-07-24
Brief Title:
Non-Interventional F-Two Isoprostane Trial NIFTI
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Non-Interventional F-Two Isoprostane Trial
Status:
COMPLETED
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NIFTI
Brief Summary:
Each year in the United States alone 300000 persons are hospitalized for traumatic brain injury with approximately one quarter dying Despite advances in aggressive neurosurgical interventions intensive care monitoring and overall supportive management many of those who do survive do not fully recover and are left with a varying degree of permanent disability It is therefore imperative that new methods of early interventions be explored
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker to help guide the timing of treatment directed specifically at early oxidant injury A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention possibly peaking within the first two hours after the initial injury
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury Blood urine and CSF if patient requires a clinically indicated ventriculostomy will be collected over the first 5 days post-injury Clinically-relevant patient progress clinically required interventions neuro-imaging results and demographics will be tracked while the patient is hospitalized with final neurological outcome measured at 3 months
One possible road to effective therapy is to examine the timing of secondary injury via a biological marker to help guide the timing of treatment directed specifically at early oxidant injury A more thorough understanding of how quickly oxidant injury occurs will allow us to direct appropriate therapies targeted directly at oxidant injury within what is currently thought to be a very narrow window of opportunity for intervention possibly peaking within the first two hours after the initial injury
Potential participants include patients between the ages of 18 and 50 years who are admitted to Parkland Memorial Hospital with a diagnosis of severe traumatic brain injury Blood urine and CSF if patient requires a clinically indicated ventriculostomy will be collected over the first 5 days post-injury Clinically-relevant patient progress clinically required interventions neuro-imaging results and demographics will be tracked while the patient is hospitalized with final neurological outcome measured at 3 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None