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History of Changes for Study: NCT03101787
Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Latest version (submitted October 14, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 30, 2017 None (earliest Version on record)
2 April 5, 2017 Arms and Interventions, Study Description, Outcome Measures, Conditions and Study Status
3 May 1, 2017 Contacts/Locations and Study Status
4 May 9, 2017 Recruitment Status, Study Status and Contacts/Locations
5 May 10, 2017 Study Status
6 November 21, 2017 Contacts/Locations, Eligibility and Study Status
7 May 29, 2018 Contacts/Locations and Study Status
8 June 13, 2018 Contacts/Locations and Study Status
9 January 14, 2019 Sponsor/Collaborators, Contacts/Locations and Study Status
10 January 30, 2019 Contacts/Locations and Study Status
11 September 17, 2019 Study Status and Contacts/Locations
12 August 11, 2022 Recruitment Status, Study Status, Contacts/Locations, Study Design and Eligibility
13 October 14, 2022 Outcome Measures and Study Status
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Study NCT03101787
Submitted Date:  March 30, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: NL58067.068.16
Brief Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Official Title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Not yet recruiting
Study Start: May 2017
Primary Completion: May 2019 [Anticipated]
Study Completion: June 2019 [Anticipated]
First Submitted: March 30, 2017
First Submitted that
Met QC Criteria:
March 30, 2017
First Posted: April 5, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 30, 2017
Last Update Posted: April 5, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Maastricht University Medical Center
Responsible Party: Sponsor
Collaborators: Nederlandse organisatie voor gezondheidsonderzoek en zorginnovatie (ZonMw)
Getinge Group
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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 OHCA presenting with VF/VT. It aims to determine the effect on survival and neurological outcome and evaluate the feasibility and cost effectiveness.
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.

Treatment of the underlying disorder is paramount, but the possibilities to perform life-saving interventions in the absence of ROSC are limited. Continued CCPR is currently the standard of care for these patients. Initiation of ECPR restores circulation, thus minimizing (or even reversing) organ damage and providing a bridge to treatment of the underlying illness, in most cases coronary artery occlusion. 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 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.

Open or close this module Conditions
Conditions: Cardiac Arrest
Out-Of-Hospital Cardiac Arrest
Sudden Cardiac Death
Keywords: ECPR
Extracorporeal Cardiopulmonary Resuscitation
OHCA
Out-of-hospital cardiac arrest
CPR
Cardiopulmonary Resuscitation
ECMO
Extracorporeal Membrane Oxygenation
Refractory cardiac arrest
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 110 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
No Intervention: CCPR protocol
Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and rapid transport to the emergency department with ongoing mechanical CPR and ACLS for the continuation of conventional cardiopulmonary resuscitation (CCPR). No special preparations for the trial are needed before the patient's arrival. Upon the patient's arrival, the standard of care (CCPR) will be continued according to ERC guidelines.
Experimental: ECPR protocol
Cardiopulmonary resuscitation (CPR) by emergency medical services (EMS) and transport to the emergency department with ongoing mechanical CPR and ACLS for initiation of extracorporeal cardiopulmonary resuscitation (ECPR). The ECPR team is mobilized while patient is still en route to the hospital. Arrest to start of cannulation time 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 still 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, continuation of chest compressions with minimization of interruptions remains essential. Cannulas are introduced into the femoral artery and vein, and advanced to the thoracic aorta and inferior caval vein, respectively.
Open or close this module Outcome Measures
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 CRF, iPCQ and 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
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 70 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  1. ≥18 - ≤70 years
  2. Witnessed OHCA
  3. Initial rhythm of VF/VT or AED administered
  4. 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. Start cannulation > 60 min after arrest
Open or close this module Contacts/Locations
Central Contact Person: Martje Suverein, MD
Email: martje.suverein@mumc.nl
Study Officials: Marcel van de Poll, MD, PhD
Principal Investigator
Maastricht UMC
Locations: Netherlands, Limburg
Maastricht UMC
Maastricht, Limburg, Netherlands
Contact:Contact: Martje Suverein, MD +3143 387 4373 martje.suverein@mumc.nl
Contact:Contact: Marcel van de Poll, MD, PhD marcel.vande.poll@mumc.nl
Contact:Sub-Investigator: Martine Bol, MSc
Contact:Sub-Investigator: Thijs Delnoij, MD
Contact:Sub-Investigator: Roberto Lorusso, MD, PhD
Contact:Sub-Investigator: Jos Maessen, MD, PhD
Contact:Principal Investigator: Marcel van de Poll, MD, PhD
Contact:Sub-Investigator: Paul Roekaerts, MD, PhD
Contact:Sub-Investigator: Patrick Weerwind, PhD
Netherlands, Noord-Brabant
Catharina Ziekenhuis
Eindhoven, Noord-Brabant, Netherlands
Netherlands, Overijssel
Isala Klinieken
Zwolle, Overijssel, Netherlands
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Links:
Available IPD/Information:

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