Hyperinvasive Approach in Cardiac Arrest

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Charles University, Czech Republic
Sponsor:
Information provided by (Responsible Party):
Jan Belohlavek, Charles University, Czech Republic
ClinicalTrials.gov Identifier:
NCT01511666
First received: January 13, 2012
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

Prague out-of Hospital Cardiac Arrest (OHCA) study is a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, extracorporeal life support (ECLS) and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care. It is hypothesized, that above stated "hyperinvasive" approach might improve outcome of out-of hospital cardiac arrest victims.


Condition Intervention Phase
Out-of Hospital Cardiac Arrest
Device: Prehospital mechanical compression device, intraarrest cooling and in hospital ECLS (LUCAS, Rhinochill, PLS ECMO)
Other: Standard care
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hyperinvasive Approach to out-of Hospital Cardiac Arrest Using Mechanical Chest Compression Device, Prehospital Intraarrest Cooling, Extracorporeal Life Support and Early Invasive Assessment Compared to Standard of Care. A Randomized Parallel Groups Comparative Study. "Prague OHCA Study"

Resource links provided by NLM:


Further study details as provided by Charles University, Czech Republic:

Primary Outcome Measures:
  • Composite endpoint of survival with good neurological outcome (CPC 1-2). [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Neurological recovery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Neurological recovery will be defined as no or minimal neurological impairment (CPC 1 or 2) at any timepoint within first 30 days after initial cardiac arrest.

  • Cardiac recovery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Cardiac recovery will be assessed by the clinical status of hemodynamic stability defined as no need for pharmacological or mechanical cardiac support. Systolic function will be measured by echocardiography .


Estimated Enrollment: 170
Study Start Date: March 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hyperinvasive arm
Hyperinvasive arm encompasses immediate institution of a mechanical chest compression device (LUCAS) and pre-hospital intraarrest cooling by Rhino-Chill device. Immediately after institution of these two devices the patients will be directly transferred to cardiac center cathlab under continuous CPR. The use of drugs and further defibrillations are on a discretion of the emergency physician. After admission to cathlab, overall status, ROSC presence and ECLS inclusion/exclusion criteria will be evaluated.
Device: Prehospital mechanical compression device, intraarrest cooling and in hospital ECLS (LUCAS, Rhinochill, PLS ECMO)
ECLS states for extracorporeal life support.
Other Names:
  • LUCAS (Lund University Cardiac Arrest System)(Physio-Control Inc./Jolife AB, Lund, Sweden) device for mechanical chest compressions.
  • Rhinochill (BeneChill, Lausanne, Switzerland)device for intraarrest cooling.
  • PLS ECMO (MAQUET Cardiopulmonary AG, Hirrlingen, Germany) device for ECLS.
Active Comparator: Standard arm
Patients in standard arm will be further managed as per recent ERC guidelines, ie. continued ACLS. The use of drugs and further defibrillations are on a discretion of the emergency physician. If ROSC is attained, patients will be transferred to the same hospital to one of intensive care units, coronary angiography/PCI will be performed only if indicated according to routine practice and mild therapeutic hypothermia will be instituted as soon as possible as per recent guidelines recommendation.
Other: Standard care
Standard care as per recent guidelines will be provided.

Detailed Description:

Background: Out of hospital cardiac arrest (OHCA) has a poor outcome. Recent non-randomized study of ECLS (extracorporeal life support) in OHCA suggested further prospective multicenter studies to define population with OHCA that would benefit from ECLS.

Aim: to perform a prospective randomized multicenter clinical study comparing use of prehospital intraarrest hypothermia, mechanical chest compression device, ECLS and early invasive investigation and treatment (coronary angiography/percutaneous coronary intervention [PCI]; pulmonary angiography/percutaneous embolectomy; aortography) in all patients with OHCA of presumed cardiac origin compared to standard of care.

Planned intervention: patients with witnessed OHCA without ROSC (return of spontaneous circulation) after a minimum of 5 minutes of ACLS by emergency medical service (EMS) team will be after fulfilling of inclusion/exclusion criteria for the study randomized in a 1:1 design to standard vs. hyperinvasive arm. Patients in standard arm will be further managed as per recent guidelines. In hyperinvasive arm, mechanical compression device together with intranasal cooling will be immediately instituted and patients will be transferred to cardiac center directly to cathlab under ongoing CPR. After admission to cathlab, overall status, ROSC and ECLS inclusion/exclusion criteria will be evaluated and in case of no contraindications to ECLS and no ROSC or ROSC with shock, veno-arterial ECLS will be started as soon as possible, not later than 60 minutes after cardiac arrest onset. After ECLS institution, mild hypothermia will be continued by means of ECLS cooling and immediate invasive investigation will be performed in all patients.

Standard postresuscitation care will follow.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • minimum of 18 and maximum of 65 years
  • witnessed out-of-hospital cardiac arrest of presumed cardiac cause
  • minimum of 5 minutes of ACLS performed by emergency medical service team without sustained ROSC
  • unconsciousness (Glasgow Coma Score < 8)
  • ECMO team and bed-capacity in cardiac center available.

Exclusion Criteria:

  • OHCA of presumed non-cardiac cause
  • unwitnessed collapse
  • pregnancy
  • sustained ROSC within 5 minutes of ACLS performed by EMS team
  • conscious patient
  • known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
  • suspected or confirmed acute stroke
  • known severe chronic organ dysfunction or other limitations in therapy
  • "do not resuscitate" order or other circumstances making 180 day survival unlikely
  • known pre-arrest cerebral performance category CPC ≥ 3.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511666

Contacts
Contact: Jan Belohlavek, MD, PhD. +420 724 371 594 jan.belohlavek@vfn.cz
Contact: Ondrej Smid, MD +420 22496 2618 ondrej.smid@vfn.cz

Locations
Czech Republic
General Teaching Hospital Recruiting
Prague, Czech Republic, 128 02
Contact: Jan Belohlavek, MD, PhD.    +420 724 371 594    jan.belohlavek@vfn.cz   
Sponsors and Collaborators
Charles University, Czech Republic
  More Information

No publications provided by Charles University, Czech Republic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Belohlavek, Jan Belohlavek, MD, PhD., Consultant in Cardiology and Critical Care, Charles University, Czech Republic
ClinicalTrials.gov Identifier: NCT01511666     History of Changes
Other Study ID Numbers: Prague OHCA study
Study First Received: January 13, 2012
Last Updated: November 3, 2013
Health Authority: Czech Republic: State Institute for Drug Control

Keywords provided by Charles University, Czech Republic:
cardiac arrest
mechanical chest compressions
intraarrest cooling
ECLS

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014