Overview

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

Status:
Completed

Trial end date:
2005-12-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Umeå University

Treatments:

Epoprostenol
Tezosentan

Criteria

Inclusion Criteria:

- traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

- pregnant or lactating women