Cardiac ArrestECPB4OHCANCT01605409
Emergency Cardiopulmonary Bypass for Cardiac Arrest
A study testing Emergency cardiopulmonary bypass under ongoing CPR and Standard ACLS in people with Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Emergency cardiopulmonary bypass under ongoing CPR and Standard ACLS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Nov 2014to May 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with witnessed out-of-hospital cardiac arrest, with presumed cardiac cause, immediate initiation of bystander CPR and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support are eligible. Patients who do achieve ROSC at first but suffer rearrest afterwards and do not achieve ROSC again after 15 minutes of advanced cardiac life support are considered eligible as well.
Who cannot join
- Patients younger than 18 years or older than 75 years
- Traumatic cardiac arrest
- Cardiac arrest due to exsanguination, strangulation, hanging or drowning
- Accidental hypothermia as a cause of cardiac arrest
- Women suffering life-threatening amniotic fluid embolism
- Cardiac arrest due to pulmonary artery embolism
Show all 19Show fewer
- Cardiac arrest due to intoxication
- Cardiac arrest due to intracranial hemorrhage
- Other initial ECG-rhythm than ventricular fibrillation
- Known or clinically apparent pregnancy
- Patients with an Allow-natural-death- (AND) or Do-not-attempt-resuscitation (DNAR) order or patients with a terminal illness
- Patients who, for any reason, can not be transported with ongoing CPR
- Insufficient quality of bystander CPR (at the discretion of the emergency physician or EMT)*
- Estimated transportation time exceeding 30 minutes
- Patients with psychiatric conditions
- Mentally handicapped patients
- Patients with severe neurological conditions
- Patients of a nursing institution or other institutionalized patients
- Ward of the state / prisoner
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University Vienna, Dept. of Emergency Medicine
Vienna, 1090
Anton N. Laggner, Prof. MD, +43140400 ext. 1964, anton.laggner@meduniwien.ac.at
Michael Holzer, Ao. Prof. MD
About this study
Official title: Emergency Cardiopulmonary Bypass After Cardiac Arrest With Ongoing Cardiopulmonary Resuscitation - a Pilot Randomized Trial
Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate.
Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body) is a method which has shown good results in case reports and animal studies for cardiac arrest care.
The study will be performed as comparison between the new treatment option of ECPB versus the standard of care treatment.
Aim of our study is to determine the feasibility of ECPB installed in an emergency department to improve the rate of patients restoration of spontaneous circulation.
Read the detailed description
Background: Out of hospital cardiac arrest is associated with a poor prognosis. Overall survival varies between 3% and 16% respectively. Measures to improve the chance of survival are urgently needed. If return of spontaneous circulation under competent cardiopulmonary resuscitation (CPR) measures is not achieved within the first 25 minutes the chance of survival decreases even further. Emergency Cardiopulmonary Bypass (ECPB) would be such a treatment option for these heavily compromised patients, as it has shown considerably good results used as resuscitation device for cardiac arrest in animal studies.
Material and Methods: This study will be performed as single center (university hospital) randomized, controlled and prospective pilot study comprising a highly experienced emergency department treating about 200 to 300 cardiac arrest patients a year. Two groups will be analyzed, a 'Standard ACLS´ group and an 'ECPB´ group. Each group will comprise 20 patients. Eligible are adult patients with witnessed out of hospital cardiac arrest, with presumed cardiac cause and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support.
Patients in the 'Standard ACLS´ group will be resuscitated until return of spontaneous circulation or termination of efforts. The 'ECPB´ group will receive ongoing cardiopulmonary resuscitation during transport to the emergency department where ECPB will be installed. Necessary diagnostic examinations and therapeutic interventions for both groups will be performed according to guidelines for post resuscitation care and good clinical practice.
Primary outcome measure is the rate of sustained restoration of spontaneous circulation according to Utstein criteria. Secondary outcome measures are 24 hours survival, survival to ICU discharge, survival to hospital discharge, rate of best neurological recovery (cerebral performance category score 1 or 2) within 6 months after cardiac arrest and modified Rankin score at 6 months after cardiac arrest.
Patients in the 'Standard ACLS´ group receive standard treatment without any potential additional risks. The 'ECPB´ group receives standard advanced cardiac life support as well and has the predicted advantage of the extracorporeal oxygenation at the emergency department and coronary intervention even before return of spontaneous circulation.
Aim of this study: To compare current standard therapy for patients after out of hospital cardiac arrest (cardiopulmonary resuscitation until return of spontaneous circulation or termination of efforts) with a new concept of transportation with ongoing cardiopulmonary reanimation and installation of ECPB at the Emergency Department to improve survival.
- Conditions
- Cardiac Arrest
- Being tested
- Emergency cardiopulmonary bypass under ongoing CPR, Standard ACLS
- Keywords
- Refractory cardiac arrest, Emergency cardiopulmonary bypass, Extracorporeal life support in cardiac arrest
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency cardiopulmonary bypass under ongoing CPRProcedure or surgery
Emergency cardiopulmonary bypass under ongoing CPR
Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department.
Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT.
Standard ACLSProcedure or surgery
Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council.
Transportation:
Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital.
Standard Post resuscitation Management:
After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group.
If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible.
| Study group | Role | What they receive |
|---|---|---|
| Standard ACLS | Active comparator | Patients in the standard ACLS group will be resuscitated until ROSC or termination of efforts. If ROSC is achieved they will be transported to the emergency department and treated according to ERC guidelines and GCP. Receives: Procedure: Standard ACLS |
| ECPB | Experimental | ACLS provided for 15 minutes by EMS personnel according to current guidelines of the ERC.
CPR during transportation will be performed by EMS personnel according to ERC guidelines.
At the ED cannulation will be performed percutaneously if feasible. The femoral artery will be cannulated with a 17-19 - Fr and the femoral vein will be cannulated simultaneously with heparin coated 19-25 - Fr catheter or a smart cannula. An antegrade 8 - Fr cannula will be placed to supply perfusion for the cannulated leg if feasible. The procedures will be performed ultrasound-guided and the size of the cannulae will be adapted according to vessel size. Correct placement of the venous cannulae will be verified via ultrasound. Cardiopulmonary bypass will be performed by using the Lifebridge(Sorin®) or the Cardiohelp(Maquet®) ECMO device, according to protocol. Receives: Procedure: Emergency cardiopulmonary bypass under ongoing CPR; Procedure: Standard ACLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of return of spontaneous circulation (ROSC)
Measured: 2-48h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2012 (estimated)
- Study startNov 2014
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Schober, Medical University of Vienna
- Investigators
- Andreas Schober, MD, Principal investigator, Medical University Vienna, Austria, Dept. of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01605409
- Sponsor's protocol ID
- KLI196
- Acronym
- ECPB4OHCA
- Status last verified
- Mar 2018
- First submitted
- 22 May 2012
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Cardiopulmonary Bypass After Cardiac Arrest With Ongoing Cardiopulmonary Resuscitation - a Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT01605409
- Acronym / sponsor ID
- ECPB4OHCA / KLI196
- Conditions
- Cardiac Arrest
- Keywords
- Refractory cardiac arrest, Emergency cardiopulmonary bypass, Extracorporeal life support in cardiac arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 24 May 2012 (estimated)
- 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.
Cardiac arrest ist associated with a very poor prognosis. Even though resuscitation algorithms and postcardiac arrest care have been improved there is an urgent need for measures leading to a higher survival rate.
Emergency cardiopulmonary bypass (ECPB - artificial heart and lung outside the patients body) is a method which has shown good results in case reports and animal studies for cardiac arrest care.
The study will be performed as comparison between the new treatment option of ECPB versus the standard of care treatment.
Aim of our study is to determine the feasibility of ECPB installed in an emergency department to improve the rate of patients restoration of spontaneous circulation.
Detailed description
Background: Out of hospital cardiac arrest is associated with a poor prognosis. Overall survival varies between 3% and 16% respectively. Measures to improve the chance of survival are urgently needed. If return of spontaneous circulation under competent cardiopulmonary resuscitation (CPR) measures is not achieved within the first 25 minutes the chance of survival decreases even further. Emergency Cardiopulmonary Bypass (ECPB) would be such a treatment option for these heavily compromised patients, as it has shown considerably good results used as resuscitation device for cardiac arrest in animal studies.
Material and Methods: This study will be performed as single center (university hospital) randomized, controlled and prospective pilot study comprising a highly experienced emergency department treating about 200 to 300 cardiac arrest patients a year. Two groups will be analyzed, a 'Standard ACLS´ group and an 'ECPB´ group. Each group will comprise 20 patients. Eligible are adult patients with witnessed out of hospital cardiac arrest, with presumed cardiac cause and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support.
Patients in the 'Standard ACLS´ group will be resuscitated until return of spontaneous circulation or termination of efforts. The 'ECPB´ group will receive ongoing cardiopulmonary resuscitation during transport to the emergency department where ECPB will be installed. Necessary diagnostic examinations and therapeutic interventions for both groups will be performed according to guidelines for post resuscitation care and good clinical practice.
Primary outcome measure is the rate of sustained restoration of spontaneous circulation according to Utstein criteria. Secondary outcome measures are 24 hours survival, survival to ICU discharge, survival to hospital discharge, rate of best neurological recovery (cerebral performance category score 1 or 2) within 6 months after cardiac arrest and modified Rankin score at 6 months after cardiac arrest.
Patients in the 'Standard ACLS´ group receive standard treatment without any potential additional risks. The 'ECPB´ group receives standard advanced cardiac life support as well and has the predicted advantage of the extracorporeal oxygenation at the emergency department and coronary intervention even before return of spontaneous circulation.
Aim of this study: To compare current standard therapy for patients after out of hospital cardiac arrest (cardiopulmonary resuscitation until return of spontaneous circulation or termination of efforts) with a new concept of transportation with ongoing cardiopulmonary reanimation and installation of ECPB at the Emergency Department to improve survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard ACLS | Active comparator | Procedure: Standard ACLSPatients in the standard ACLS group will be resuscitated until ROSC or termination of efforts. If ROSC is achieved they will be transported to the emergency department and treated according to ERC guidelines and GCP. |
| ECPB | Experimental | Procedure: Emergency cardiopulmonary bypass under ongoing CPR, Procedure: Standard ACLSACLS provided for 15 minutes by EMS personnel according to current guidelines of the ERC. CPR during transportation will be performed by EMS personnel according to ERC guidelines. At the ED cannulation will be performed percutaneously if feasible. The femoral artery will be cannulated with a 17-19 - Fr and the femoral vein will be cannulated simultaneously with heparin coated 19-25 - Fr catheter or a smart cannula. An antegrade 8 - Fr cannula will be placed to supply perfusion for the cannulated leg if feasible. The procedures will be performed ultrasound-guided and the size of the cannulae will be adapted according to vessel size. Correct placement of the venous cannulae will be verified via ultrasound. Cardiopulmonary bypass will be performed by using the Lifebridge(Sorin®) or the Cardiohelp(Maquet®) ECMO device, according to protocol. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with witnessed out-of-hospital cardiac arrest, with presumed cardiac cause, immediate initiation of bystander CPR and without return of spontaneous circulation after a minimum of 15 minutes of advanced cardiac life support are eligible. Patients who do achieve ROSC at first but suffer rearrest afterwards and do not achieve ROSC again after 15 minutes of advanced cardiac life support are considered eligible as well.
Key exclusion criteria (19 listed)
- Patients younger than 18 years or older than 75 years
- Traumatic cardiac arrest
- Cardiac arrest due to exsanguination, strangulation, hanging or drowning
- Accidental hypothermia as a cause of cardiac arrest
- Women suffering life-threatening amniotic fluid embolism
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 |
|---|---|---|
| Emergency cardiopulmonary bypass under ongoing CPREmergency cardiopulmonary bypass under ongoing CPR Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department. Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT. | Procedure or surgery | ECPB |
| Standard ACLSStandard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council. Transportation: Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital. Standard Post resuscitation Management: After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group. If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible. | Procedure or surgery | ECPB, Standard ACLS |
Primary outcome
Rate of return of spontaneous circulation (ROSC)
Time frame: 2-48h
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
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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.
Andreas Schober, MD principal investigator
Medical University Vienna, Austria, Dept. of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency cardiopulmonary bypass under ongoing CPR and Standard ACLS in people with Cardiac Arrest, run by Medical University of Vienna at 1 site in Austria.
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 1 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andreas Schober, MD (+4340400 ext. 1964, andreas.schober@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of return of spontaneous circulation (ROSC) (time frame: 2-48h). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2018.