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

Umeå University

Status and phase: Completed; Phase 1

Conditions: Traumatic Brain Injury

Treatments: Drug: epoprostenol versus normal saline; Drug: normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01363583

151:633=01

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 15 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• traumatic brain injury, Glasgow coma scale ≤ 8

Exclusion criteria

• pregnant or lactating women

Trial design

48 participants in 2 patient groups, including a placebo group

epoprostenol, Flolan®

Active Comparator group

Description:

Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis

Treatment:

Drug: epoprostenol versus normal saline

normal saline

Placebo Comparator group

Description:

Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis

Treatment:

Drug: epoprostenol versus normal saline

Drug: normal saline