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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pär Johansson
• Collaborators: Aalborg University Hospital; Aarhus University Hospital; Odense University Hospital; Oslo University Hospital
• Treatments: Epoprostenol; Iloprost; Tezosentan

Criteria

Inclusion Criteria:

• Age ≥ 18 years

• Present with clinical signs of hemorrhagic shock (defined by systolic blood pressure <90 millimetre of mercury (mmHg) or use of pre-hospital blood transfusion).

• Activation of local massive transfusion protocol and initiation of the first transfusion after admission.

• Randomised within 5 hours of injury and 3 hours of admission to the emergency department of the participating trial site.

• Consent is provided on behalf of incapacitated patients by Scientific Guardian

Exclusion Criteria:

• Withdrawal from active therapy

• Known hypersensitivity to Iloprost.

• Pregnancy (non-pregnancy confirmed by patient having a negative urine or plasma choriogonadotropin (hCG) or being postmenopausal defined as females at 60 years old and beyond)

• Known severe heart failure (New York Heart Association (NYHA) class IV)

• Suspected acute coronary syndrome

• Estimated weight < 40 kg