Traumatic Brain Injury
Conditions
Keywords
traumatic brain injury
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.
Interventions
DRUGepoprostenol versus normal saline
0.5 ng/kilogram/minute during 4 days
DRUGnormal saline
0.5-1.5 ml/hour during 4 days
Sponsors
Umeå University
Study design
Allocation
RANDOMIZED
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* traumatic brain injury, Glasgow coma scale ≤ 8
Exclusion criteria
* pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo | 24 hours |
Secondary
| Measure | Time frame |
|---|---|
| Levels of systemic inflammatory markers | 4 days |
Countries
Sweden
Outcome results
None listed