Early Initiation of Extracorporeal Life Support in Refractory OHCA
NCT ID: NCT03101787
Last Updated: 2022-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
134 participants
INTERVENTIONAL
2017-05-01
2022-02-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Witnessed OHCA (by bystanders)
3. Initial rhythm of VF/VT or AED administered
4. Bystander BLS
Exclusion Criteria
2. Terminal heart failure (NYHA III or IV)
3. Severe pulmonary disease (COPD GIII of GIV)
4. Disseminated oncological disease
5. Obvious or suspected pregnancy
6. Bilateral femoral bypass surgery
7. Known contraindications for ECPR
8. Known pre-arrest CPC-score of 3 or 4
9. Known limitations in therapy or a Do Not Resuscitate-order
10. Multitrauma (Injury Severity Score \>15)
11. Expected time-to-start cannulation \> 60 minutes
18 Years
70 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Getinge Group
OTHER
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marcel van de Poll, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Maastricht UMC
Locations
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Maastricht UMC
Maastricht, Limburg, Netherlands
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Academisch Medisch Centrum
Amsterdam, North Holland, Netherlands
Isala Klinieken
Zwolle, Overijssel, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, Netherlands
St. Antonius Hospital
Nieuwegein, Utrecht, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Countries
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References
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Ubben JFH, Heuts S, Delnoij TSR, Suverein MM, Hermanides RC, Otterspoor LC, Kraemer CVE, Vlaar APJ, van der Heijden JJ, Scholten E, den Uil C, Dos Reis Miranda D, Akin S, de Metz J, van der Horst ICC, Winkens B, Maessen JG, Lorusso R, van de Poll MCG. Favorable resuscitation characteristics in patients undergoing extracorporeal cardiopulmonary resuscitation: A secondary analysis of the INCEPTION-trial. Resusc Plus. 2024 May 13;18:100657. doi: 10.1016/j.resplu.2024.100657. eCollection 2024 Jun.
Heuts S, van de Koolwijk AF, Gabrio A, Ubben JFH, van der Horst ICC, Delnoij TSR, Suverein MM, Maessen JG, Lorusso R, van de Poll MCG. Extracorporeal life support in cardiac arrest: a post hoc Bayesian re-analysis of the INCEPTION trial. Eur Heart J Acute Cardiovasc Care. 2024 Feb 16;13(2):191-200. doi: 10.1093/ehjacc/zuad130.
Suverein MM, Delnoij TSR, Lorusso R, Brandon Bravo Bruinsma GJ, Otterspoor L, Elzo Kraemer CV, Vlaar APJ, van der Heijden JJ, Scholten E, den Uil C, Jansen T, van den Bogaard B, Kuijpers M, Lam KY, Montero Cabezas JM, Driessen AHG, Rittersma SZH, Heijnen BG, Dos Reis Miranda D, Bleeker G, de Metz J, Hermanides RS, Lopez Matta J, Eberl S, Donker DW, van Thiel RJ, Akin S, van Meer O, Henriques J, Bokhoven KC, Mandigers L, Bunge JJH, Bol ME, Winkens B, Essers B, Weerwind PW, Maessen JG, van de Poll MCG. Early Extracorporeal CPR for Refractory Out-of-Hospital Cardiac Arrest. N Engl J Med. 2023 Jan 26;388(4):299-309. doi: 10.1056/NEJMoa2204511.
Bol ME, Suverein MM, Lorusso R, Delnoij TSR, Brandon Bravo Bruinsma GJ, Otterspoor L, Kuijpers M, Lam KY, Vlaar APJ, Elzo Kraemer CV, van der Heijden JJ, Scholten E, Driessen AHG, Montero Cabezas JM, Rittersma SZH, Heijnen BG, Taccone FS, Essers B, Delhaas T, Weerwind PW, Roekaerts PMHJ, Maessen JG, van de Poll MCG. Early initiation of extracorporeal life support in refractory out-of-hospital cardiac arrest: Design and rationale of the INCEPTION trial. Am Heart J. 2019 Apr;210:58-68. doi: 10.1016/j.ahj.2018.12.008. Epub 2018 Dec 14.
Other Identifiers
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NL58067.068.16
Identifier Type: -
Identifier Source: org_study_id
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