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

Traumatic Brain Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01363583
• Other study ID #: 151:633=01
• Status: Completed
• Phase: Phase 1
• First received: May 27, 2011
• Last updated: May 27, 2011
• Start date: January 2002
• Est. completion date: December 2005

Study information

• Verified date: September 2001
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• traumatic brain injury, Glasgow coma scale = 8

Exclusion Criteria:

• pregnant or lactating women

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Traumatic Brain Injury

Intervention

Drug:
• epoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
• normal saline
0.5-1.5 ml/hour during 4 days

Locations

Country	Name	City	State
Sweden	Umea university	Umea

Sponsors (1)

Lead Sponsor	Collaborator
Umeå University

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Olivecrona M, Rodling-Wahlström M, Naredi S, Koskinen LO. Prostacyclin treatment in severe traumatic brain injury: a microdialysis and outcome study. J Neurotrauma. 2009 Aug;26(8):1251-62. doi: 10.1089/neu.2008-0605. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo		24 hours	No
Secondary	Levels of systemic inflammatory markers		4 days	No