Iloprost therapy and blood pressure target in resuscitated cardiac arrest

Safety and efficacy of low-dose Iloprost administration and blood pressure target in addition to standard therapy, as compared to standard therapy alone, in post-cardiac- arrest-syndrome patients – a randomized, controlled, double-blinded investigator-initiated trial - ENDO-RCA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-002998-11-DK

Enrollment

Unknown

Registered

2014-09-23

Start date

2014-11-14

Completion date

Unknown

Last updated

2017-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest MedDRA version: 18.1 Level: LLT Classification code 10007517 Term: Cardiac arrest transient System Organ Class: 100000004849

Interventions

Trade Name: Ilomedin Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: ILOPROST TROMETAMOL CAS Number: 0 Current Sponsor code: NA Concentration unit: µg/ml mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age =18 years 2. OHCA of presumed cardiac cause 3. Sustained ROSC* 4. Unconsciousness (GCS =65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

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

Measure

Time frame

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

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary endpoints: Change in functional hemostatic blood test (Thromboelastography (TEG) and whole blood platelet aggregometry (Multiplate)) and blood cell and endothelial cell derived microparticles from baseline to 48 hours post-randomization. Feasibility of blood pressure target intervention (target 90%). Interaction of primary end-points and blood pressure target. Blood pressure target impact on levels of NSE at 48h and 72 h post inclusion Tertiary endpoints: (1) Days of vasopressor, ventilator and renal replacement therapy post-randomization. (2) Changes in SOFA score from baseline to 48 h and day 5 and 7 post-randomization. (3) Neurological function graded by modified Rankong Scale (mRS) and Cerebral Performance Category (CPC) at 180 days. (4) Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more/24 hours). (5) Use of blood products (in ICU) post-randomization. (6) Difference in day 7, 30 and 180 day mortality between patients receiving active treatment (lloprost) and placebo. EGFR and urine output on day 2 and 3, need for renal replacement therapy during the ICU stay.;Timepoint(s) of evaluation of this end point: Secondary endpoint: 48 hours post-randomization Tertiary endpoints: evaluated througout the 48 hour treatment period and after 7, 30, 90 and 180 days	—

Measure

Time frame

Secondary end point(s): Secondary endpoints: Change in functional hemostatic blood test (Thromboelastography (TEG) and whole blood platelet aggregometry (Multiplate)) and blood cell and endothelial cell derived microparticles from baseline to 48 hours post-randomization. Feasibility of blood pressure target intervention (target 90%). Interaction of primary end-points and blood pressure target. Blood pressure target impact on levels of NSE at 48h and 72 h post inclusion Tertiary endpoints: (1) Days of vasopressor, ventilator and renal replacement therapy post-randomization. (2) Changes in SOFA score from baseline to 48 h and day 5 and 7 post-randomization. (3) Neurological function graded by modified Rankong Scale (mRS) and Cerebral Performance Category (CPC) at 180 days. (4) Severe bleeding (intracranial or clinical bleeding with the use of 3 RBC units or more/24 hours). (5) Use of blood products (in ICU) post-randomization. (6) Difference in day 7, 30 and 180 day mortality between patients receiving active treatment (lloprost) and placebo. EGFR and urine output on day 2 and 3, need for renal replacement therapy during the ICU stay.;Timepoint(s) of evaluation of this end point: Secondary endpoint: 48 hours post-randomization Tertiary endpoints: evaluated througout the 48 hour treatment period and after 7, 30, 90 and 180 days

—

Countries

Denmark

Contacts

Public ContactSponsor (Pär I. Johansson)

Rigshospitalet, Capital Region Bloodbank 2034, Section for Transfusion Medicine

per.johansson@regionh.dk004523 72 92 02

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026