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

Phase 1

Completed

• Conditions: Traumatic Brain Injury
• Interventions: Drug: epoprostenol versus normal saline; Drug: normal saline

• Registration Number: NCT01363583
• Lead Sponsor: Umeå University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2001-09
• Study Start: 2002-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Last Update Submitted: 2011-05-27
• Study First Posted: 2011-06-01
• Last Update Posted: 2011-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria

• pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
epoprostenol, Flolan®	epoprostenol versus normal saline	Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis
normal saline	epoprostenol versus normal saline	Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
normal saline	normal saline	Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis

Primary Outcome Measures

Name	Time	Method
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo	24 hours

Secondary Outcome Measures

Name	Time	Method
Levels of systemic inflammatory markers	4 days

Trial Locations

Locations (1)

Umea university; 🇸🇪 Umea, Sweden