Ignite Creation Date:
2024-05-05 @ 11:35 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01363583
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2011-05-27
Brief Title:
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury
Sponsor:
Umeå University
Organization:
Umeå University
Study Overview
Official Title:
Prostacyclin Treatment in Severe Traumatic Brain Injury a Microdialysis and Outcome Study
Status:
COMPLETED
Status Verified Date:
2001-09
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:
None
Brief Summary:
This study is a prospective consecutive double-blinded randomized study on the effect of PGI2 prostacyclin epoprostenol Flolan versus placebo salinein patients with severe traumatic brain injury All patients with severe traumatic brain injury were eligible for inclusion Inclusion criteria verified traumatic brain injury Glasgow Coma Score GCS at intubation and sedation of 8 age 15-70 years a first-recorded cerebral perfusion pressure CPP of 10 mm Hg and arrival within 24 hours after trauma
Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactatepyruvate ratioas measured by cerebral microdialysis after 24 hours of treatment
A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers measured by different cytokines
Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactatepyruvate ratioas measured by cerebral microdialysis after 24 hours of treatment
A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers measured by different cytokines
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