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Completed

NCT Number: NCT01363583

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

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.

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Umea university

Umeå, 90187, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion criteria

  • pregnant or lactating women

Treatment and study plan

epoprostenol versus normal saline

Drug

0.5 ng/kilogram/minute during 4 days

Other names: Flolan®, Normal saline

normal saline

Drug

0.5-1.5 ml/hour during 4 days

Primary outcomes

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

    Time frame: 24 hours

Secondary outcomes

  1. Levels of systemic inflammatory markers

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Jun 1, 2011
Registry last updated
Jun 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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