Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03101787|
Recruitment Status : Recruiting
First Posted : April 5, 2017
Last Update Posted : January 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Arrest Out-Of-Hospital Cardiac Arrest Sudden Cardiac Death||Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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
- QALY's [ Time Frame: 3 months, 6 months and 1 year ]Quality-adjusted-life-years using EQ-5D-5L
- 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)
- Survival status at 3 months, 6 months and 1 year [ Time Frame: 3 months, 6 months and 1 year ]
- 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
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
|Contact: Martje Suverein, MD||(+31)43 387 firstname.lastname@example.org|
|Maastricht, Limburg, Netherlands|
|Contact: Martje Suverein, MD +3143 387 6385 email@example.com|
|Contact: Marcel van de Poll, MD, PhD firstname.lastname@example.org|
|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|
|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|
|Contact: Joris van der Heijden, MD|
|Principal Investigator:||Marcel van de Poll, MD, PhD||Maastricht UMC|