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
- Conditions
- Shock-induced endotheliopathy in trauma patientsMedDRA version: 20.1Level: LLTClassification code 10044528Term: Traumatic injurySystem Organ Class: 100000004863Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]
- Registration Number
- EUCTR2019-000936-24-DK
- Lead Sponsor
- Section for Transfusion Medicine, Capital Region Blood Bank, Copenhagen University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
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 3 hours 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
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
- Secondary Outcome Measures
Name Time Method