Acute Heart FailurePC-ECMONCT03508505
Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
An observational study of Acute Heart Failure and Low Output Heart Failure, run by Turku University Hospital at 1 site in Finland.
Trial summary
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Heart Failure, Low Output Heart Failure, Cardiac Output, Low
- What is being tested?
- Venoarterial extracorporeal oxygenation
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 1 siteFinland
- Study dates
- 1 Jan 2018to 31 Dec 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients who required VA-ECMO for acute heart failure occurring during the index hopsitalization for elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
Who may be able to join
- Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
Who cannot join
- Any VA-ECMO implanted before index surgical procedure;
- Patients who underwent postoperatively veno-venous ECMO;
- Patients who required VA-ECMO after heart transplantation;
- Patients who required VA-ECMO after any left ventricular assist device.
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study.
Read more
In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy.
The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.
Read the detailed description
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Prolonged aortic cross-clamping, ischemia-reperfusion injury, suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous and small size series of patients who underwent different cardiac surgery procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and, in view of the development of perfusion technology and perioperative care, this does not provide an exact measure of the current benefits of this treatment strategy. Importantly, the role of intra-aortic balloon pump, left ventricular venting, duration of VA-ECMO and hospital experience should be evaluated. The investigators sought to investigate these issues in a large multicenter study.
Patients and methods Patients who were treated with VA-ECMO for cardiac low-output after adult cardiac surgery (other than heart transplantation and/or implantation of a left ventricular assist device) in 21 centers of cardiac surgery from January 2010 to December 2017.
Eligibility criteria
- Patients aged > 18 years;
- Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery because of postoperative low-cardiac output syndrome and/or acute respiratory failure.
Exclusion criteria
- Patients aged < 18 years;
- Any VA-ECMO implanted before index surgical procedure;
- Patients who underwent postoperatively veno-venous ECMO;
- Patients who required VA-ECMO after heart transplantation;
- Patients who required VA-ECMO after any left ventricular assist device.
Definition criteria Definition criteria and units of measurements are reported beside each baseline, operative and postoperative variables in the electronic datasheet.
Outcomes
- Hospital death
- Late death
- Stroke
- Tracheostomy
- Gastrointestinal complications
- Deep sternal wound infection
- Vascular access site infection
- Blood stream infection
- Peripheral vascular injury
- Major lower limb amputation
- New onset dialysis
- Peak postoperative serum creatinine level
- Nadir postoperative pH during VA-ECMO
- Peak postoperative arterial lactate level
- Nadir postoperative hemoglobin level
- Chest drainage output 24 h after surgery
- Number of red blood cells units transfused intra- and postoperatively
- Reoperation for intrathoracic bleeding
- Reoperation for peripheral cannulation-related bleeding
- Intensive care unit length of stay
- Death on VA-ECMO
Analysis of clinical results
The aim of this registry is to perform a number of analysis evaluating:
- Early and late survival of postcardiotomy VA-ECMO;
- Predictors and causes of in-hospital death after successful weaning from postcardiotomy VA-ECMO;
- Comparative analysis of peripheral versus central postcardiotomy VA-ECMO;
- VA-ECMO plus intra-aortic baloon pump vs. isolated VA-ECMO;
- Determinants of outcome after prolonged postcardiotomy VA-ECMO (>5 days).
Publication of results The results of these studies will be submitted for publication to international, peer-reviewed journals in the fields of critical care, cardiology or cardiac surgery.
- Conditions
- Acute Heart Failure, Low Output Heart Failure, Cardiac Output, Low, Extracorporeal Membrane Oxygenation, Cardiac Surgery, Venoarterial Extracorporeal Membrane Oxygenation
- Being tested
- Venoarterial extracorporeal oxygenation
- Keywords
- Acute Heart Failure, Low Output Heart Failure, Cardiac Low Output, Extracorporeal Membrane Oxygenation, ECMO, Venoarterial Extracorporeal membrane oxygenation, Cardiac Surgery
- Medical subject headings
- Cardiac Output, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venoarterial extracorporeal oxygenationDevice
Also called Cardiac surgery, Coronary artery bypass grafting, Aortic valve replacement, Mitral valve repair
Veno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital death
All-cause death
Measured: Up to 30 days after the index cardiac surgery
Secondary outcomes (20)
Late death
All-cause death
Measured: Up to 7-year follow-up after the index cardiac surgery
Stroke
Ischemic infarction or hemorrhagic injury of the brain
Measured: Up to 30 days after the index cardiac surgery
Tracheostomy
Respiratory failure requiring tracheostomy
Measured: Up to 30 days after the index cardiac surgery
Gastrointestinal complications
Gastrointestinal complications requiring surgical treatment
Measured: Up to 30 days after the index cardiac surgery
Deep sternal wound infection
Deep sternal wound infection or mediastinitis
Measured: Up to 30 days after the index cardiac surgery
Vascular access site infection
Infection secondary to any vascular access
Measured: Up to 30 days after the index cardiac surgery
Blood stream infection
Blood stream infection detected at blood cultures
Measured: Up to 30 days after the index cardiac surgery
Peripheral vascular injury
Any aortic and/or peripheral artery complications related to VA-ECMO
Measured: Up to 30 days after the index cardiac surgery
Major lower limb amputation
Major lower limb amputation
Measured: Up to 30 days after the index cardiac surgery
New onset dialysis
New onset dialysis
Measured: Up to 30 days after the index cardiac surgery
Peak postoperative serum creatinine level
Peak postoperative serum creatinine level
Measured: Up to 30 days after the index cardiac surgery
Nadir postoperative pH during VA-ECMO
Nadir postoperative pH during VA-ECMO
Measured: Up to 30 days after the index cardiac surgery
Peak postoperative arterial lactate level
Peak postoperative arterial lactate level
Measured: Up to 30 days after the index cardiac surgery
Nadir postoperative hemoglobin level
Nadir postoperative hemoglobin level
Measured: Up to 30 days after the index cardiac surgery
Chest drainage output 24 h after surgery
Chest drainage output 24 h after surgery
Measured: Up to 24 hours after the index cardiac surgery
Number of red blood cells units transfused intra- and postoperatively
Number of red blood cells units transfused intra- and postoperatively
Measured: Up to 30 days after the index cardiac surgery
Reoperation for intrathoracic bleeding
Reoperation for intrathoracic bleeding
Measured: Up to 30 days after the index cardiac surgery
Reoperation for peripheral cannulation-related bleeding
Reoperation for peripheral cannulation-related bleeding
Measured: Up to 30 days after the index cardiac surgery
Intensive care unit length of stay
Intensive care unit length of stay
Measured: Up to 30 days after the index cardiac surgery
Death on VA-ECMO
Death on VA-ECMO
Measured: Up to 30 days after the index cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start1 Jan 2018
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Heart FailureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, Ospedali Riuniti Trieste, Universitätsklinikum Hamburg-Eppendorf, University of Burgundy, CHU de Reims, Rennes University Hospital, Henri Mondor University Hospital, Glenfield Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University Hospital Muenster, Institute for Clinical and Experimental Medicine, Medical University of Vienna, University Hospital, Udine, Italy, Golden Jubilee National Hospital, Heinrich-Heine University, Duesseldorf, Helsinki University Central Hospital, Helios Research Center, Sahlgrenska University Hospital, Lund University Hospital, Prince Sultan Cardiac Center, Adult Cardiology Department.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508505
- Sponsor's protocol ID
- T3/2018
- Acronym
- PC-ECMO
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2018
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon request, the investigators will ask the Ethical Committee of the participating centers for permission to share all individual participant data included in this registry with the exception of data through which the patients could be identified.
Publications
Biancari F, Perrotti A, Ruggieri VG, Mariscalco G, Dalen M, Dell'Aquila AM, Jonsson K, Ragnarsson S, Di Perna D, Bounader K, Gatti G, Juvonen T, Alkhamees K, Yusuff H, Loforte A, Lechiancole A, Chocron S, Pol M, Spadaccio C, Pettinari M, De Keyzer D, Fiore A, Welp H. Five-year survival after post-cardiotomy veno-arterial extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):595-601. doi: 10.1093/ehjacc/zuaa039.
PubMed 33580776Mariscalco G, Fiore A, Ragnarsson S, El-Dean Z, Jonsson K, Dalen M, Fux T, Ruggieri VG, Gatti G, Juvonen T, Zipfel S, Dell'Aquila AM, Perrotti A, Bounader K, Settembre N, Loforte A, Livi U, Pol M, Spadaccio C, Pettinari M, Reichart D, Alkhamees K, Welp H, Maselli D, Lichtenberg A, Biancari F; PC-ECMO group. Venoarterial Extracorporeal Membrane Oxygenation After Surgical Repair of Type A Aortic Dissection. Am J Cardiol. 2020 Jun 15;125(12):1901-1905. doi: 10.1016/j.amjcard.2020.03.012. Epub 2020 Mar 31.
PubMed 32305219
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postcardiotomy Venoarterial Extracorporeal Membrane Oxygenation
- ClinicalTrials.gov ID
- NCT03508505
- Acronym / sponsor ID
- PC-ECMO / T3/2018
- Conditions
- Acute Heart Failure, Low Output Heart Failure, Cardiac Output, Low, Extracorporeal Membrane Oxygenation, Cardiac Surgery, Venoarterial Extracorporeal Membrane Oxygenation
- Keywords
- Acute Heart Failure, Low Output Heart Failure, Cardiac Low Output, Extracorporeal Membrane Oxygenation, ECMO, Venoarterial Extracorporeal membrane oxygenation, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- Karolinska Institutet, Ospedali Riuniti Trieste, Universitätsklinikum Hamburg-Eppendorf, University of Burgundy, CHU de Reims, Rennes University Hospital, Henri Mondor University Hospital, Glenfield Hospital, IRCCS Azienda Ospedaliero-Universitaria di Bologna, University Hospital Muenster, Institute for Clinical and Experimental Medicine, Medical University of Vienna, University Hospital, Udine, Italy, Golden Jubilee National Hospital, Heinrich-Heine University, Duesseldorf, Helsinki University Central Hospital, Helios Research Center, Sahlgrenska University Hospital, Lund University Hospital, Prince Sultan Cardiac Center, Adult Cardiology Department.
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 25 Apr 2018 (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.
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous patient populations, which prevent conclusive results on the benefits of VA-ECMO in this setting. This issue will be investigated in the present retrospective European multicenter study.
In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous populations of patients who underwent different cardiac procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and this does not provide an exact measure of the benefits of this treatment strategy.
The possible benefits of using VA-ECMO after adult cardiac surgery will be investigated in this retrospective European multicenter study.
Detailed description
Cardiac surgery can be not infrequently complicated by cardiac low-output syndrome due to critical preoperative conditions such as cardiogenic shock, poor left ventricular function and severe myocardial ischemia. Prolonged aortic cross-clamping, ischemia-reperfusion injury, suboptimal myocardial protection, technical errors at graft anastomoses or of prosthesis implantation, and hibernating myocardium may further contribute to cardiac low-output syndrome occurring immediately or shortly after cardiac surgery. In this setting, veno-arterial extracorporeal oxygenation (VA-ECMO) is the only means to provide cardiopulmonary support to recovery or as bridge to transplantation.
Data on the real benefit of VA-ECMO after cardiac surgery is limited and often derived from heterogeneous and small size series of patients who underwent different cardiac surgery procedures. Patients with cardiac low-output after surgery for aortic dissection or valve surgery are expected to have different baseline characteristics (such as age and comorbidities) and underlying cardiac disease than patients undergoing isolated coronary surgery. Furthermore, available studies included patients operated two decades ago and, in view of the development of perfusion technology and perioperative care, this does not provide an exact measure of the current benefits of this treatment strategy. Importantly, the role of intra-aortic balloon pump, left ventricular venting, duration of VA-ECMO and hospital experience should be evaluated. The investigators sought to investigate these issues in a large multicenter study.
Patients and methods Patients who were treated with VA-ECMO for cardiac low-output after adult cardiac surgery (other than heart transplantation and/or implantation of a left ventricular assist device) in 21 centers of cardiac surgery from January 2010 to December 2017.
Eligibility criteria
- Patients aged > 18 years;
- Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery because of postoperative low-cardiac output syndrome and/or acute respiratory failure.
Exclusion criteria
- Patients aged < 18 years;
- Any VA-ECMO implanted before index surgical procedure;
- Patients who underwent postoperatively veno-venous ECMO;
- Patients who required VA-ECMO after heart transplantation;
- Patients who required VA-ECMO after any left ventricular assist device.
Definition criteria Definition criteria and units of measurements are reported beside each baseline, operative and postoperative variables in the electronic datasheet.
Outcomes
- Hospital death
- Late death
- Stroke
- Tracheostomy
- Gastrointestinal complications
- Deep sternal wound infection
- Vascular access site infection
- Blood stream infection
- Peripheral vascular injury
- Major lower limb amputation
- New onset dialysis
- Peak postoperative serum creatinine level
- Nadir postoperative pH during VA-ECMO
- Peak postoperative arterial lactate level
- Nadir postoperative hemoglobin level
- Chest drainage output 24 h after surgery
- Number of red blood cells units transfused intra- and postoperatively
- Reoperation for intrathoracic bleeding
- Reoperation for peripheral cannulation-related bleeding
- Intensive care unit length of stay
- Death on VA-ECMO
Analysis of clinical results
The aim of this registry is to perform a number of analysis evaluating:
- Early and late survival of postcardiotomy VA-ECMO;
- Predictors and causes of in-hospital death after successful weaning from postcardiotomy VA-ECMO;
- Comparative analysis of peripheral versus central postcardiotomy VA-ECMO;
- VA-ECMO plus intra-aortic baloon pump vs. isolated VA-ECMO;
- Determinants of outcome after prolonged postcardiotomy VA-ECMO (>5 days).
Publication of results The results of these studies will be submitted for publication to international, peer-reviewed journals in the fields of critical care, cardiology or cardiac surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who required VA-ECMO for acute heart failure occurring during the index hopsitalization for elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
Key inclusion criteria (1 listed)
- Patients who required VA-ECMO after elective, urgent or emergency adult cardiac surgery such as coronary surgery, heart valve surgery and/or aortic root surgery.
Key exclusion criteria (4 listed)
- Any VA-ECMO implanted before index surgical procedure;
- Patients who underwent postoperatively veno-venous ECMO;
- Patients who required VA-ECMO after heart transplantation;
- Patients who required VA-ECMO after any left ventricular assist device.
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 |
|---|---|---|
| Venoarterial extracorporeal oxygenationAlso: Cardiac surgery, Coronary artery bypass grafting, Aortic valve replacement, Mitral valve repairVeno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation. | Device | – |
Primary outcome
Hospital death
Time frame: Up to 30 days after the index cardiac surgery
All-cause death
20 secondary outcomes
Late death
Time frame: Up to 7-year follow-up after the index cardiac surgery
Stroke
Time frame: Up to 30 days after the index cardiac surgery
Tracheostomy
Time frame: Up to 30 days after the index cardiac surgery
Gastrointestinal complications
Time frame: Up to 30 days after the index cardiac surgery
Deep sternal wound infection
Time frame: Up to 30 days after the index cardiac surgery
Vascular access site infection
Time frame: Up to 30 days after the index cardiac surgery
Blood stream infection
Time frame: Up to 30 days after the index cardiac surgery
Peripheral vascular injury
Time frame: Up to 30 days after the index cardiac surgery
Major lower limb amputation
Time frame: Up to 30 days after the index cardiac surgery
New onset dialysis
Time frame: Up to 30 days after the index cardiac surgery
Peak postoperative serum creatinine level
Time frame: Up to 30 days after the index cardiac surgery
Nadir postoperative pH during VA-ECMO
Time frame: Up to 30 days after the index cardiac surgery
Peak postoperative arterial lactate level
Time frame: Up to 30 days after the index cardiac surgery
Nadir postoperative hemoglobin level
Time frame: Up to 30 days after the index cardiac surgery
Chest drainage output 24 h after surgery
Time frame: Up to 24 hours after the index cardiac surgery
Number of red blood cells units transfused intra- and postoperatively
Time frame: Up to 30 days after the index cardiac surgery
Reoperation for intrathoracic bleeding
Time frame: Up to 30 days after the index cardiac surgery
Reoperation for peripheral cannulation-related bleeding
Time frame: Up to 30 days after the index cardiac surgery
Intensive care unit length of stay
Time frame: Up to 30 days after the index cardiac surgery
Death on VA-ECMO
Time frame: Up to 30 days after the index cardiac surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Derived from this study: PubMed 33580776Biancari F, Perrotti A, Ruggieri VG, Mariscalco G, Dalen M, Dell'Aquila AM, Jonsson K, Ragnarsson S, Di Perna D, Bounader K, Gatti G, Juvonen T, Alkhamees K, Yusuff H, Loforte A, Lechiancole A, Chocron S, Pol M, Spadaccio C, Pettinari M, De Keyzer D, Fiore A, Welp H. Five-year survival after post-cardiotomy veno-arterial extracorporeal membrane oxygenation. Eur Heart J Acute Cardiovasc Care. 2021 Aug 24;10(6):595-601. doi: 10.1093/ehjacc/zuaa039.
- Derived from this study: PubMed 32305219Mariscalco G, Fiore A, Ragnarsson S, El-Dean Z, Jonsson K, Dalen M, Fux T, Ruggieri VG, Gatti G, Juvonen T, Zipfel S, Dell'Aquila AM, Perrotti A, Bounader K, Settembre N, Loforte A, Livi U, Pol M, Spadaccio C, Pettinari M, Reichart D, Alkhamees K, Welp H, Maselli D, Lichtenberg A, Biancari F; PC-ECMO group. Venoarterial Extracorporeal Membrane Oxygenation After Surgical Repair of Type A Aortic Dissection. Am J Cardiol. 2020 Jun 15;125(12):1901-1905. doi: 10.1016/j.amjcard.2020.03.012. Epub 2020 Mar 31.
- Individual participant dataSharing planned: Undecided. Upon request, the investigators will ask the Ethical Committee of the participating centers for permission to share all individual participant data included in this registry with the exception of data through which the patients could be identified.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Heart Failure and Low Output Heart Failure, run by Turku University Hospital at 1 site in Finland.
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 4 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 11 Mar 2020. 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 Finland. 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?
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?
Hospital death (time frame: Up to 30 days after the index cardiac surgery). 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 NCT03508505, which also lists 2 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 11 Mar 2020.