Overview

Infusion of Prostacyclin vs Placebo for 72-hours in Trauma Patients With Haemorrhagic Shock Suffering From Organ Failure

Status:
Active, not recruiting

Trial end date:
2021-09-30

Target enrollment:

Participant gender:

Summary

A multicenter, randomized (1:1, iloprost: placebo), placebo controlled, blinded, investigator-initiated phase 2b trial in trauma patients with haemorrhagic shock and shock induced endotheliopathy (SHINE), investigating the efficacy and safety of continuous intravenous administrating of iloprost (1 ng/kg/min) versus placebo for 72-hours, in a total of 220 patients. The study hypothesis is that iloprost may be beneficial as an endothelial rescue treatment as it is anticipated to deactivate the endothelium and restore vascular integrity in trauma patients with haemorrhagic shock (SHINE) suffering from organ failure caused by endothelial breakdown, ultimately improving survival.

Phase:

Phase 2

Details

Lead Sponsor:

Pär Johansson

Collaborators:

Aalborg University Hospital
Aarhus University Hospital
Odense University Hospital
Oslo University Hospital

Treatments:

Epoprostenol
Iloprost
Tezosentan