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

May 27, 2011 updated by: Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umea, Sweden, 90187
        • Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

  • pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: epoprostenol, Flolan®
Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis
Drug: epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
Other Names:
  • Normal saline
  • Flolan®
Placebo Comparator: normal saline
Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis
Drug: epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
Other Names:
  • Normal saline
  • Flolan®
Drug: normal saline
0.5-1.5 ml/hour during 4 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Levels of systemic inflammatory markers
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Lars-Owe Koskinen, Professor, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

December 1, 2005

Study Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 27, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 27, 2011

Last Verified

September 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 151:633=01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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