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Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)

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ClinicalTrials.gov Identifier: NCT03101787
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
ZonMw: The Netherlands Organisation for Health Research and Development
Getinge Group
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:
Despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of patients in cardiac arrest fail to achieve sustained return of spontaneous circulation. The INCEPTION trial is a multicenter, randomized controlled trial that will explore extracorporeal cardiopulmonary resuscitation (ECPR) in patients in refractory out-of-hospital cardiac arrest (OHCA) presenting with ventricular fibrillation or tachycardia. It aims to determine the effect on survival and neurological outcome. Additionally, it will evaluate the feasibility and cost-effectiveness of ECPR.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Out-Of-Hospital Cardiac Arrest Sudden Cardiac Death Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR) Not Applicable

Detailed Description:

There are approximately 275,000 cases of out-of-hospital cardiac arrest (OHCA) per year in Europe, of which two-thirds have a primary cardiac origin. However, despite adequate conventional cardiopulmonary resuscitation (CCPR) and attempted defibrillation, a considerable number of these patients fail to achieve sustained return of spontaneous circulation (ROSC).

Treatment of the underlying cause of the arrest, in most cases coronary artery occlusion, is paramount. But in the absence of ROSC, the possibilities to perform these life-saving interventions are limited. Continued CCPR is currently the standard of care for these patients. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR) restores circulation, with the potential to minimize (or even reversing) organ damage, prevent re-arrest due to ischemia-triggered myocardial dysfunction and providing a bridge to possible diagnosis and treatment. Several studies have demonstrated that ECPR is feasible and may be advantageous with respect to survival and neurological outcome.

The INCEPTION trial aims to compare ECPR to CCPR in the population that is expected to benefit the most from this intervention: young patients presenting with ventricular fibrillation or tachycardia (VF/VT) and a refractory cardiac arrest. Furthermore, it will provide data on the cost-effectiveness of this intervention, which to date has been unavailable. Although the costs may prove to be high, the gain in quality-adjusted life years (QALY's) may be substantial given the fact that most patients are relatively young and the current alternative carries a poor prognosis. This can determine whether ECPR should be pursued as a standard of care in patients with refractory arrest.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: CCPR protocol

Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and rapid transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).

Clinical Upon the patient's arrival, the standard of care (CCPR) will be continued according to ERC guidelines.

No special preparations for the trial are needed before the patient's arrival.

Experimental: ECPR protocol

Preclinical Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and transport to the emergency department with ongoing mechanical CPR and advanced cardiac life support (ACLS).

Clinical The ECPR team is mobilized while the patient is transported to the hospital. Initiation of extracorporeal cardiopulmonary resuscitation (ECPR).

Time from arrest to start of cannulation is < 60 minutes.

Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)

In addition to the routine response team, the ECLS team are called to the ED while the patient is transported to the hospital.

The team consists of a physician skilled and qualified in femoral cannulation, a perfusionist and a scrub nurse.

Upon the patient's arrival at the emergency department, CPR will be continued, with continuation of mechanical chest compressions with minimization of interruptions.

Time from arrest to start of cannulation is < 60 minutes.





Primary Outcome Measures :
  1. 30-day survival rate with favorable neurological status [ Time Frame: 30 days ]
    Favorable neurological status is defined as 1 or 3 on the using Cerebral Performance Category scale


Secondary Outcome Measures :
  1. QALY's [ Time Frame: 3 months, 6 months and 1 year ]
    Quality-adjusted-life-years using EQ-5D-5L

  2. Costs of ECPR and CCPR [ Time Frame: 3 months, 6 months and 1 year ]
    Using the Case Report Form, Productivity Cost Questionnaire (iPCQ) and Medical Consumption Questionnaire (iMCQ)

  3. Survival status at 3 months, 6 months and 1 year [ Time Frame: 3 months, 6 months and 1 year ]
  4. Neurologic status at 3 months, 6 months and 1 year [ Time Frame: 3 months, 6 months and 1 year ]
    Favorable neurological status is defined as 1 or 3 on the using Cerebral Performance Category scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. ≥18 - ≤70 years
  2. Witnessed OHCA
  3. Initial rhythm of VF/VT or AED administered
  4. Bystander BLS
  5. No ROSC

Exclusion Criteria:

  1. ROSC
  2. Terminal heart failure (NYHA III or IV)
  3. Severe pulmonary disease (COPD GIII of GIV)
  4. Oncological disease
  5. Pregnancy
  6. Bilateral femoral bypass surgery
  7. Pre-arrest CPC-score of 3 or 4
  8. Advanced directive
  9. Multitrauma (ISS >15)
  10. Start cannulation > 60 min after arrest

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03101787


Contacts
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Contact: Martje Suverein, MD (+31)43 387 6385 martje.suverein@mumc.nl

Locations
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Netherlands
Maastricht UMC Recruiting
Maastricht, Limburg, Netherlands
Contact: Martje Suverein, MD    +3143 387 6385    martje.suverein@mumc.nl   
Contact: Marcel van de Poll, MD, PhD       marcel.vande.poll@mumc.nl   
Sub-Investigator: Martine Bol, MSc         
Sub-Investigator: Thijs Delnoij, MD         
Sub-Investigator: Roberto Lorusso, MD, PhD         
Sub-Investigator: Jos Maessen, MD, PhD         
Principal Investigator: Marcel van de Poll, MD, PhD         
Sub-Investigator: Paul Roekaerts, MD, PhD         
Sub-Investigator: Patrick Weerwind, PhD         
Catharina Ziekenhuis Not yet recruiting
Eindhoven, Noord-Brabant, Netherlands
Contact: Ka Yan Lam, MD         
Academisch Medisch Centrum Recruiting
Amsterdam, Noord-Holland, Netherlands
Contact: Alexander Vlaar, MD, PhD         
Isala Klinieken Recruiting
Zwolle, Overijssel, Netherlands
Contact: George Brandon Bravo Bruinsma, MD, PhD         
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3435 CM
Contact: Erik Scholten, MD         
Leids Universitair Medisch Centrum Recruiting
Leiden, Zuid-Holland, Netherlands
Contact: Carlos Elzo Kraemer, MD, PhD         
Universitair Medisch Centrum Utrecht Recruiting
Utrecht, Netherlands
Contact: Joris van der Heijden, MD         
Sponsors and Collaborators
Maastricht University Medical Center
ZonMw: The Netherlands Organisation for Health Research and Development
Getinge Group
Investigators
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Principal Investigator: Marcel van de Poll, MD, PhD Maastricht UMC

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT03101787     History of Changes
Other Study ID Numbers: NL58067.068.16
First Posted: April 5, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Maastricht University Medical Center:
ECPR
Extracorporeal CardioPulmonary Resuscitation
OHCA
Out-of-Hospital Cardiac Arrest
CPR
CardioPulmonary Resuscitation
ECMO
ExtraCorporeal Membrane Oxygenation
Refractory Cardiac Arrest

Additional relevant MeSH terms:
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Heart Arrest
Out-of-Hospital Cardiac Arrest
Death
Death, Sudden, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Death, Sudden