NCT01363583

Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Umeå University · Academic / Other
• Sex: All
• Age: 15 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in 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 lactate/pyruvate ratio,as 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.

Conditions

• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	epoprostenol versus normal saline	0.5 ng/kilogram/minute during 4 days
DRUG	normal saline	0.5-1.5 ml/hour during 4 days

Timeline

• Start date: 2002-01-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2011-06-01
• Last updated: 2011-06-01

Locations

1 site across 1 country: Sweden