Efficacy and safety of 72-hour infusion of Prostacyclin (1 ng/kg/min) in trauma patients with haemorrhagic shock suffering from organ failure caused by endothelial breakdow

Phase 1

• Conditions: Shock-induced endotheliopathy in trauma patients; MedDRA version: 20.1Level: LLTClassification code 10044528Term: Traumatic injurySystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2019-000936-24-NO
• Lead Sponsor: Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Age = 18 years
Present with clinical signs of hemorrhagic shock (defined by systolic blood pressure <90 mmHg or use of pre-hospital blood transfusion).
Activation of internal massive transfusion protocol and initiation of the first transfusion after admission.
Randomised within 5 hours of injury and 5 hour of admission to the ED of the participating trial site.
Consent is provided on behalf of incapacitated patients by Scientific Guardian
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 140
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Withdrawal from active therapy
Known hypersensitivity to Ilomedin®.
Pregnancy (non-pregnancy confirmed by patient having a negative urine- or blood hCG or being postmenopausal defined as females beyond 60 years old or at the investigators discretion)
Known severe heart failure (NYHA class IV)
Suspected acute coronary syndrome
Estimated weight < 40 kg

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective in this trial is to investigate whether continuos infusion of iloprost at a dose of 1 ng/kg/min for 72-hours is safe and significantly increase the number of ICU free days, within 28 days from admission compared to infusion of placebo in trauma patients with haemorrhagic shock and SHINE.;Secondary Objective: Not applicaple;Primary end point(s): Number of ICU free days, ;Timepoint(s) of evaluation of this end point: within 28 days of admission

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 28 and 90-day all-cause mortality<br>Hospital length of stay <br>Vasopressor-free days within 28 days<br>Ventilator-free days within 28 days<br>Renal replacement free days within 28 days<br>Number of serious adverse reactions and serious adverse events within the first 4 days of admission.<br>;Timepoint(s) of evaluation of this end point: Day 28 and 90