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

Sponsor
Umeå University (Other)
Overall Status
Completed
CT.gov ID
NCT01363583
Collaborator
(none)
48
Enrollment
1
Location
2
Arms
47
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: epoprostenol versus normal saline
  • Drug: normal saline
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study
Study Start Date :
Jan 1, 2002
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

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:
  • Flolan®
  • Normal saline

    		•
    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:
  • Flolan®
  • Normal saline

    • Drug: normal saline
    0.5-1.5 ml/hour during 4 days

    Outcome Measures

    Primary Outcome Measures

    1. Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo [24 hours]

    Secondary Outcome Measures

    1. Levels of systemic inflammatory markers [4 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • traumatic brain injury, Glasgow coma scale ≤ 8
    Exclusion Criteria:
    • pregnant or lactating women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Umea university Umea Sweden 90187

    Sponsors and Collaborators

    • Umeå University

    Investigators

    • Principal Investigator: Lars-Owe Koskinen, Professor, Umea university

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01363583
    Other Study ID Numbers:
    • 151:633=01
    First Posted:
    Jun 1, 2011
    Last Update Posted:
    Jun 1, 2011
    Last Verified:
    Sep 1, 2001
    Keywords provided by , ,
    traumatic brain injury
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Epoprostenol
    Tezosentan

    Study Results

    No Results Posted as of Jun 1, 2011