Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363583
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : June 1, 2011
Sponsor:
Information provided by:
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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: epoprostenol versus normal saline Drug: normal saline Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : January 2002
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Levels of systemic inflammatory markers [ Time Frame: 4 days ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion Criteria:

  • pregnant or lactating women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363583


Locations
Layout table for location information
Sweden
Umea university
Umea, Sweden, 90187
Sponsors and Collaborators
Umeå University
Investigators
Layout table for investigator information
Principal Investigator: Lars-Owe Koskinen, Professor Umea university
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Professor Lars-Owe Koskine, Umea university
ClinicalTrials.gov Identifier: NCT01363583    
Other Study ID Numbers: 151:633=01
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 1, 2011
Last Verified: September 2001
Keywords provided by Umeå University:
traumatic brain injury
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Epoprostenol
Tezosentan
Antihypertensive Agents
Platelet Aggregation Inhibitors
Vasodilator Agents