Iloprost therapy and blood pressure target in resuscitated cardiac arrest

Phase 1

• Conditions: Cardiac Arrest; MedDRA version: 18.1Level: LLTClassification code 10007517Term: Cardiac arrest transientSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-002998-11-DK
• Lead Sponsor: Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09-23
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age =18 years
2. OHCA of presumed cardiac cause
3. Sustained ROSC*
4. Unconsciousness (GCS <8) (patients not able to obey verbal
commands) after sustained ROSC
5. Target temperature management is indicated.
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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Conscious patients (obeying verbal commands)
2. Females of childbearing potential (unless a negative HCG test can rule
out pregnancy within the inclusion window)
3. In-hospital cardiac arrest (IHCA)
4. OHCA of presumed non-cardiac cause, e.g. after trauma or
dissection/rupture of major artery OR Cardiac arrest caused by initial
hypoxia (i.e. drowning, suffocation, hanging).
5. Known congenital bleeding diathesis (medically induced coagulopathy
due to treatment with Vitamin K antagonists, Thrombininhibitors, Factor
Xa inihbitors, ADP-receptor inhibitors, Aspirin, Asasantin, Persantin,
NSAID, unfractionated and low molecular weight heparin does NOT
exclude the patient).
6. Suspected or confirmed acute intracranial bleeding
7. Suspected or confirmed acute stroke
8. Unwitnessed asystole
9. Known limitations in therapy and Do Not Resuscitate-order
10. Known disease making 180 days survival unlikely
11. Known pre-arrest CPC 3 or 4
12. >4 hours (240 minutes) from ROSC to screening
13. Systolic blood pressure <80 mm Hg in spite of fluid
loading/vasopressor and/or inotropic medication/intra aortic balloon
pump/axial flow device*
14. Temperature on admission <30°C.
15. Known allergy to Prostacyclin analogues

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluating the safety and efficacy of low-dose Iloprost administration and blood pressure in<br>addition to standard therapy, as compared to standard therapy alone, in<br>post-cardiac-arrest-syndrome patients. ;Secondary Objective: NA;Primary end point(s): Change in biomarkers indicative of endothelial activation and damage<br>(sE-selectin, syndecan-1, thrombomodulin, sVE-cadherin, nucleosomes)<br>and sympathoadrenal overactivation (Epinephrine/norepinephrine) from<br>baseline to 48 hours post-randomization. ;Timepoint(s) of evaluation of this end point: 48 hours post-randomization