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

NCT01363583 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2011-06-01

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Umeå University

    lead OTHER

Principal Investigators

  • Lars-Owe Koskinen, Professor · Umea university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE

Eligibility

Min Age
15 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2005-12-31
Completion
2005-12-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01363583 on ClinicalTrials.gov