C.Surgical Procedure; CardiacEVADONCT01805466
Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)
A study testing EVADO and Conventional CPB in people with C.Surgical Procedure; Cardiac, run by IRCCS San Raffaele Roma at 4 sites in Italy.
Trial summary
The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- What is being tested?
- EVADO and Conventional CPB
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 4 sitesItaly
- Study dates
- Oct 2012to Jul 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria:
- Written informed consent
- Age 18-85 years
Who cannot join
- Severe renal or liver failure
- Uncompensated diabetes
- Autoimmune disease requiring immunosuppressant therapy
- Coagulation disorders
- Emergent or redo surgery
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Anthea Hospital
Bari
Maria Cecilia Hospital
Cotignola, 48010
Città di Lecce Hospital
Lecce
ICLAS Rapallo
Rapallo
About this study
Official title: A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.
Read the detailed description
The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial.
Participating centres are selected based on previous experience with the use of the EVADO system.
Patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened.
This study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.
- Conditions
- C.Surgical Procedure; Cardiac
- Being tested
- EVADO, Conventional CPB
- Keywords
- Extracorporeal Vacuum Assisted Device Optimised (EVADO)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVADODevice
EVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution.
Conventional CPBDevice
conventional miniature cardiopulmonary bypass technique
| Study group | Role | What they receive |
|---|---|---|
| EVADO | Experimental | The E.V.A.D.O. system is made of the following components:
* The ADMIRAL oxygenator, that requires low priming volumes (, has a limited contact surface and contains an accessory independent cardiotomy reservoir, allowing separation of pericardial suction blood.
* The HARMONY Smart Suction System, which allows automatic regulation of a pumpless extracavity blood sucker, whose rates and pressures depend on whether suction is required for blood/air surfaces (skimming), or for fluids (pooled).
* Paediatric circuits with 3/8" tubing for both arterial and venous lines. Receives: Device: EVADO |
| Conventional CPB | Active comparator | conventional cardiopulmonary by-pass (CPB) system Receives: Device: Conventional CPB |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
The primary efficacy endpoint is the composite of in-hospital mortality, defined as death of any cause occurring before hospital discharge, myocardial infarction, stroke; severe renal failure; severe liver failure; severe cardio-respiratory failure; multiorgan failure; need for left ventricular support device; need for dialysis or ultrafiltration: post-operative bleeding; atrial fibrillation.
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (10)
Individual components of the primary end-point
outcome parameters recorded in the postoperative period: Myocardial infarction
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Stroke
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Severe renal failure (greater than 2-fold increase in creatinine levels)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Multiorgan failure (MOF)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Need for left ventricular support device (IABCP or similar)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Need for dialysis or ultrafiltration
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Postoperative bleeding
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Atrial fibrillation
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Severe liver failure (greater than 2-fold increase in AST (aspartate aminotransferase), ALT (alanine aminotransferase) and y-GT (y-glutamyltransferase) levels)
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
outcome parameters recorded in the postoperative period:
Severe cardio-respiratory failure
Measured: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startOct 2012
- Primary completionDec 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele Roma
- Sponsor type
- University, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation
- Responsible party
- Sponsor
- Investigators
- Giuseppe Nasso, MD, Principal investigator, IRCCS San Raffaele Pisana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805466
- Sponsor's protocol ID
- GR-2009-1591573
- Acronym
- EVADO
- Status last verified
- Jun 2023
- First submitted
- 26 Feb 2013
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome
- ClinicalTrials.gov ID
- NCT01805466
- Acronym / sponsor ID
- EVADO / GR-2009-1591573
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- Extracorporeal Vacuum Assisted Device Optimised (EVADO)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- IRCCS San Raffaele RomaUniversity, hospital or other
- Collaborators
- Ettore Sansavini Health Science Foundation
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 6 Mar 2013 (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.
The primary purpose of this study is to assess the effects of the use of EVADO with respect to a conventional cardio-pulmonary bypass (CBP) system on surgical morbidity and mortality. As secondary aim this study wants to conduct appropriate laboratory investigations in order to detect the major biological mechanisms potentially responsible for the beneficial effects of the EVADO system on the coagulation cascade and inflammatory activation.
Detailed description
The present study is designed as a prospective, multicentre, randomized, open label, controlled, 2-arm parallel group, superiority trial.
Participating centres are selected based on previous experience with the use of the EVADO system.
Patients elected to open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination in the participating centers will be screened.
This study as secondary aim wants to confirm the results of earlier investigation by a multicentre trial conducted on a larger population of patients undergoing a wide spectrum of open heart cardiac operations and either assess a number of cost-efficacy-efficiency indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EVADO | Experimental | Device: EVADOThe E.V.A.D.O. system is made of the following components: * The ADMIRAL oxygenator, that requires low priming volumes (, has a limited contact surface and contains an accessory independent cardiotomy reservoir, allowing separation of pericardial suction blood. * The HARMONY Smart Suction System, which allows automatic regulation of a pumpless extracavity blood sucker, whose rates and pressures depend on whether suction is required for blood/air surfaces (skimming), or for fluids (pooled). * Paediatric circuits with 3/8" tubing for both arterial and venous lines. |
| Conventional CPB | Active comparator | Device: Conventional CPBconventional cardiopulmonary by-pass (CPB) system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients elected to undergo open heart surgery for a variety of cardiac conditions related to coronary, valvular or aortic disease or their combination and fulfilling the following additional criteria:
- Written informed consent
- Age 18-85 years
Key exclusion criteria (5 listed)
- Severe renal or liver failure
- Uncompensated diabetes
- Autoimmune disease requiring immunosuppressant therapy
- Coagulation disorders
- Emergent or redo surgery
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 |
|---|---|---|
| EVADOEVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution. | Device | EVADO |
| Conventional CPBconventional miniature cardiopulmonary bypass technique | Device | Conventional CPB |
Primary outcome
composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
The primary efficacy endpoint is the composite of in-hospital mortality, defined as death of any cause occurring before hospital discharge, myocardial infarction, stroke; severe renal failure; severe liver failure; severe cardio-respiratory failure; multiorgan failure; need for left ventricular support device; need for dialysis or ultrafiltration: post-operative bleeding; atrial fibrillation.
10 secondary outcomes
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Individual components of the primary end-point
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
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 22 Jun 2023.
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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.
Giuseppe Nasso, MD principal investigator
IRCCS San Raffaele Pisana
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVADO and Conventional CPB in people with C.Surgical Procedure; Cardiac, run by IRCCS San Raffaele Roma at 4 sites in Italy.
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 3 inclusion and 5 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. 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?
composite of in-hospital mortality and clinical and outcome parameters recorded in the post-operative period (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks). 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 22 Jun 2023.