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NCT Number: NCT01805466

Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO)

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.

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Key information

Conditions

C.Surgical Procedure; Cardiac

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anthea Hospital, Bari, Italy

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Severe renal or liver failure
  • Uncompensated diabetes
  • Autoimmune disease requiring immunosuppressant therapy
  • Coagulation disorders
  • Emergent or redo surgery

Treatment and study plan

EVADO

Device

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 CPB

Device

conventional miniature cardiopulmonary bypass technique

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    outcome parameters recorded in the postoperative period: Myocardial infarction

  2. 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

    outcome parameters recorded in the postoperative period:

    Stroke

  3. 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

    outcome parameters recorded in the postoperative period:

    Severe renal failure (greater than 2-fold increase in creatinine levels)

  4. 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

    outcome parameters recorded in the postoperative period:

    Multiorgan failure (MOF)

  5. 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

    outcome parameters recorded in the postoperative period:

    Need for left ventricular support device (IABCP or similar)

  6. 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

    outcome parameters recorded in the postoperative period:

    Need for dialysis or ultrafiltration

  7. 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

    outcome parameters recorded in the postoperative period:

    Postoperative bleeding

  8. 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

    outcome parameters recorded in the postoperative period:

    Atrial fibrillation

  9. 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

    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)

  10. 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

    outcome parameters recorded in the postoperative period:

    Severe cardio-respiratory failure

Other outcomes

  1. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Total duration of hospital admission [Time Frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks] [Designated as safety issue: Yes]

  2. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Duration of ICU stay

  3. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Time to extubation

  4. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Total postoperative blood loss and blood transfusion volume

  5. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Total hospitalization costs

  6. Other pre-specified outcome measures

    Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks

    • Cost-efficiency assessment

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele Roma

Other

Collaborators

  • Ettore Sansavini Health Science Foundation

Registry information

Official study title

A New Cardiopulmonary By-pass System That Minimizes Haemodilution, Hemolysis and Systemic Inflammation. Effects on Organ Damage and Surgical Outcome

Acronym: EVADO

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Mar 6, 2013
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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