Cardiac ArrestINCEPTIONNCT03101787
Early Initiation of Extracorporeal Life Support in Refractory OHCA
A study testing Extracorporeal cardiopulmonary resuscitation (ECPR) in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by Maastricht University Medical Center at 10 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cardiac Arrest, Out-Of-Hospital Cardiac Arrest, Sudden Cardiac Death
- What is being tested?
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 10 sitesNetherlands
- Study dates
- 1 May 2017to 10 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 - ≤70 years
- Witnessed OHCA (by bystanders)
- Initial rhythm of VF/VT or AED administered
- Bystander BLS
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Netherlands10 sites
Academisch Medisch Centrum
Amsterdam, North Holland
Onze Lieve Vrouwen Gasthuis
Amsterdam
Catharina Ziekenhuis
Eindhoven, North Brabant
Leids Universitair Medisch Centrum
Leiden, South Holland
Maastricht UMC
Maastricht, Limburg
St. Antonius Hospital
Nieuwegein, Utrecht, 3435 CM
Erasmus MC
Rotterdam
HagaZiekenhuis
The Hague
Universitair Medisch Centrum Utrecht
Utrecht
Isala Klinieken
Zwolle, Overijssel
About this study
Official title: Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
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.
Read the 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.
- Being tested
- Extracorporeal cardiopulmonary resuscitation (ECPR)
- Keywords
- ECPR, Extracorporeal CardioPulmonary Resuscitation, OHCA, Out-of-Hospital Cardiac Arrest, CPR, CardioPulmonary Resuscitation, ECMO, ExtraCorporeal Membrane Oxygenation, Refractory Cardiac Arrest
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest, Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extracorporeal cardiopulmonary resuscitation (ECPR)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day survival rate with favorable neurological status
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale
Measured: 30 days
Secondary outcomes (15)
Neurological outcome on the CPC scale
Does ECPR improve the neurological outcome at 30 days, 3 months, 6 months and 12 months on the CPC scale
Measured: 30 days, 3 months, 6 months and 12 months
Quality Adjusted Life Years (QALY's)
Does ECPR improve the amount of Quality Adjusted Life Years (QALY's) at 30 days, 3 months, 6 months and 12 months
Measured: 30 days, 3 months, 6 months and 12 months
Reason for discontinuation of treatment between the treatment groups
Is there a difference in reason for discontinuation of treatment between the treatment groups
Measured: Within 1 year
Time to return of circulation
What is the time to return of circulation
Measured: Within 1 year
Additional costs of ECPR with respect to CCPR
What are the additional costs of ECPR with respect to CCPR
Measured: 1 year
Costs per gained QALY for ECPR vs. CCPR
What are the costs per gained QALY for ECPR vs. CCPR
Measured: 1 year
Length of stay at the ICU
Is there a difference in length of stay at the ICU between the treatment groups
Measured: 1 year
Length of stay at the hospital
Is there a difference in length of stay at the hospital between the treatment groups
Measured: 1 year
Duration of clinical rehabilitation time
Is there a difference in the duration of clinical rehabilitation time
Measured: 1 year
Duration of mechanical ventilation
Is there a difference in the duration of mechanical ventilation between treatment groups
Measured: 1 year
Need for renal replacement therapy
Is there a difference in need for renal replacement therapy between the treatment groups
Measured: 1 year
Acute kidney injury according to the RIFLE criteria
Is there a difference in acute kidney injury according to the RIFLE criteria
Measured: 1 year
Time to target hypothermia
Is there a difference in time to target hypothermia between the treatment groups
Measured: 1 year
Difference in metabolic markers between treatment groups
Is there a difference in metabolic markers such as (1) pH, (2) etCO2, (3) ScVO2 and (4) lactate at arrival at the ED, right after initialization of circulation (either by ROSC or ECPR), 1, 2, 3, 4, 5 and 6 hours after return of circulation and at 1, 2, 3, 4, 5 and 6 days after the OHCA between the treatment groups
Measured: 6 days
Difference in metabolic markers between between the survivors and non-survivors
Is there a difference in metabolic markers such as (1) pH, (2) etCO2, (3) ScVO2 and (4) lactate at arrival at the ED, right after initialization of circulation (either by ROSC or ECPR), 1, 2, 3, 4, 5 and 6 hours after return of circulation and at 1, 2, 3, 4, 5 and 6 days after the OHCA between the survivors and non-survivors
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start1 May 2017
- Primary completion10 Feb 2021
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Getinge Group
- Responsible party
- Sponsor
- Investigators
- Marcel van de Poll, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101787
- Sponsor's protocol ID
- NL58067.068.16
- Acronym
- INCEPTION
- Status last verified
- Aug 2022
- First submitted
- 30 Mar 2017
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41243868Ubben 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.
PubMed 38778803Heuts 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.
PubMed 37872725Suverein 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.
PubMed 36720132Bol 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.
PubMed 30738245
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Initiation of Extracorporeal Life Support in Refractory OHCA (INCEPTION)
- ClinicalTrials.gov ID
- NCT03101787
- Acronym / sponsor ID
- INCEPTION / NL58067.068.16
- Keywords
- ECPR, Extracorporeal CardioPulmonary Resuscitation, OHCA, Out-of-Hospital Cardiac Arrest, CPR, CardioPulmonary Resuscitation, ECMO, ExtraCorporeal Membrane Oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Getinge Group
- Study start
- 1 May 2017 (actual)
- Primary completion
- 10 Feb 2021 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: Extracorporeal cardiopulmonary resuscitation (ECPR)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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 - ≤70 years
- Witnessed OHCA (by bystanders)
- Initial rhythm of VF/VT or AED administered
- Bystander BLS
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | ECPR protocol |
Primary outcome
30-day survival rate with favorable neurological status
Time frame: 30 days
Favorable neurological status is defined as 1 or 2 on the using Cerebral Performance Category scale
15 secondary outcomes
Neurological outcome on the CPC scale
Time frame: 30 days, 3 months, 6 months and 12 months
Quality Adjusted Life Years (QALY's)
Time frame: 30 days, 3 months, 6 months and 12 months
Reason for discontinuation of treatment between the treatment groups
Time frame: Within 1 year
Time to return of circulation
Time frame: Within 1 year
Additional costs of ECPR with respect to CCPR
Time frame: 1 year
Costs per gained QALY for ECPR vs. CCPR
Time frame: 1 year
Length of stay at the ICU
Time frame: 1 year
Length of stay at the hospital
Time frame: 1 year
Duration of clinical rehabilitation time
Time frame: 1 year
Duration of mechanical ventilation
Time frame: 1 year
Need for renal replacement therapy
Time frame: 1 year
Acute kidney injury according to the RIFLE criteria
Time frame: 1 year
Time to target hypothermia
Time frame: 1 year
Difference in metabolic markers between treatment groups
Time frame: 6 days
Difference in metabolic markers between between the survivors and non-survivors
Time frame: 6 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 41243868Verberght 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.
- Derived from this study: PubMed 38778803Ubben 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.
- Derived from this study: PubMed 37872725Heuts 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.
- Derived from this study: PubMed 36720132Suverein 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.
- Derived from this study: PubMed 30738245Bol 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.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel van de Poll, MD, PhD principal investigator
Maastricht UMC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extracorporeal cardiopulmonary resuscitation (ECPR) in people with Cardiac Arrest and Out-Of-Hospital Cardiac Arrest, run by Maastricht University Medical Center at 10 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day survival rate with favorable neurological status (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03101787, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.