Iloprost in Traumatic Hemorrhagic Shock
Trial question
What is the role of iloprost in trauma patients with hemorrhagic shock?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
21.0% female
79.0% male
N = 229
229 patients (49 female, 180 male).
Inclusion criteria: trauma patients with hemorrhagic shock.
Key exclusion criteria: withdrawal from active therapy; hypersensitivity to iloprost; pregnancy; severe HF; suspected acute coronary syndrome; estimated weight < 40 kg.
Interventions
N=119 iloprost (72 hours infusion at a dose of 1 ng/kg/min).
N=110 placebo (matching placebo).
Primary outcome
Number of intensive care unit-free days alive within 28 days
15.64 days
13.99 days
15.6 days
11.7 days
7.8 days
3.9 days
0.0 days
Iloprost
Placebo
No significant
difference ↔
No significant difference in the number of ICU-free days alive within 28 days (15.64 days vs. 13.99 days; MD 1.63, 95% CI -1.38 to 4.64).
Secondary outcomes
No significant difference in death at day 28 (18.8% vs. 19.6%; OR 1.01, 95% CI 0.51 to 2).
Significant decrease in mean hospital length of stay (19.96 days vs. 27.32 days; MD -7.84, 95% CI -14.02 to -1.66).
No significant difference in mean ventilator-free days within 28 days (18.03 days vs. 16.4 days; MD 1.58, 95% CI -1.47 to 4.63).
Safety outcomes
No significant differences in serious adverse reactions and events within 7 days, 24-hour and 28-day transfusion requirements.
Conclusion
In trauma patients with hemorrhagic shock, iloprost was not superior to placebo with respect to number of ICU-free days alive within 28 days.
Reference
Pär I Johansson, Christian Fenger Eriksen, Pernille E Bovbjerg et al. Prostacyclin in trauma patients with hemorrhagic shock-A Randomized Clinical Trial. J Trauma Acute Care Surg. 2024 Mar 1;96(3):476-481.
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