NCT03101787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 5, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2022

Completed
Last Updated

October 18, 2022

Status Verified

August 1, 2022

Enrollment Period

3.8 years

First QC Date

March 30, 2017

Last Update Submit

October 14, 2022

Conditions

Cardiac ArrestOut-Of-Hospital Cardiac ArrestSudden Cardiac Death

Keywords

ECPRExtracorporeal CardioPulmonary ResuscitationOHCAOut-of-Hospital Cardiac ArrestCPRCardioPulmonary ResuscitationECMOExtraCorporeal Membrane OxygenationRefractory Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • 30-day survival rate with favorable neurological status

    Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale

    30 days

Secondary Outcomes (15)

  • Neurological outcome on the CPC scale

    30 days, 3 months, 6 months and 12 months

  • Quality Adjusted Life Years (QALY's)

    30 days, 3 months, 6 months and 12 months

  • Reason for discontinuation of treatment between the treatment groups

    Within 1 year

  • Time to return of circulation

    Within 1 year

  • Additional costs of ECPR with respect to CCPR

    1 year

  • +10 more secondary outcomes

Study Arms (2)

CCPR protocol

NO INTERVENTION

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.

ECPR protocol

EXPERIMENTAL

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)

Interventions

Extracorporeal cardiopulmonary resuscitation (ECPR)PROCEDURE

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.

ECPR protocol

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 - ≤70 years
  • Witnessed OHCA (by bystanders)
  • Initial rhythm of VF/VT or AED administered
  • Bystander BLS

You may not qualify if:

  • ROSC within 15 minutes of conventional CPR with sustained hemodynamic recovery
  • Terminal heart failure (NYHA III or IV)
  • Severe pulmonary disease (COPD GIII of GIV)
  • Disseminated oncological disease
  • Obvious or suspected pregnancy
  • Bilateral femoral bypass surgery
  • Known contraindications for ECPR
  • Known pre-arrest CPC-score of 3 or 4
  • Known limitations in therapy or a Do Not Resuscitate-order
  • Multitrauma (Injury Severity Score \>15)
  • Expected time-to-start cannulation \> 60 minutes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Maastricht UMC

Maastricht, Limburg, Netherlands

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, Netherlands

Location

Academisch Medisch Centrum

Amsterdam, North Holland, Netherlands

Location

Isala Klinieken

Zwolle, Overijssel, Netherlands

Location

Leids Universitair Medisch Centrum

Leiden, South Holland, Netherlands

Location

St. Antonius Hospital

Nieuwegein, Utrecht, 3435 CM, Netherlands

Location

Onze Lieve Vrouwen Gasthuis

Amsterdam, Netherlands

Location

Erasmus MC

Rotterdam, Netherlands

Location

HagaZiekenhuis

The Hague, Netherlands

Location

Universitair Medisch Centrum Utrecht

Utrecht, Netherlands

Location

Related Publications (5)

  • Verberght HCR, Delnoij TSR, Suverein MM, Lunsing J, Hermanides RC, Otterspoor L, Elzo Kraemer CV, Vlaar APJ, van der Heijden JJ, Scholten E, Uil CAD, Miranda DDR, Akin S, Metz J, van der Horst ICC, Mathot BJ, de Jonge J, Nijboer MWN, de Meijer VE, Sanders JSF, Christiaans MHL, van Zuilen AD, Hagenaars H, Wind J, Danhof M, Olde Damink SWM, Winkens B, Maessen JG, Lorusso R, van de Poll MCG; INCEPTION-investigators. Organ Donor Potential After Extracorporeal Cardiopulmonary Resuscitation for Out-of-Hospital Cardiac Arrest: A Post-Hoc Analysis of a Randomized Controlled Trial. Clin Transplant. 2025 Nov;39(11):e70382. doi: 10.1111/ctr.70382.

    PMID: 41243868DERIVED

  • 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.

    PMID: 38778803DERIVED

  • 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.

    PMID: 37872725DERIVED

  • 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.

    PMID: 36720132DERIVED

  • 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.

    PMID: 30738245DERIVED

MeSH Terms

Conditions

Heart ArrestOut-of-Hospital Cardiac ArrestDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marcel van de Poll, MD, PhD

    Maastricht UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2017

First Posted

April 5, 2017

Study Start

May 1, 2017

Primary Completion

February 10, 2021

Study Completion

February 10, 2022

Last Updated

October 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(10)