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

NCT01805466 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-06-22

No results posted yet for this study

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. 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.

Conditions

  • C.Surgical Procedure; Cardiac

Interventions

DEVICE

EVADO

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.

DEVICE

Conventional CPB

conventional miniature cardiopulmonary bypass technique

Sponsors & Collaborators

  • Ettore Sansavini Health Science Foundation

    collaborator OTHER

  • IRCCS San Raffaele Roma

    lead OTHER

Principal Investigators

  • Giuseppe Nasso, MD · IRCCS San Raffaele Pisana

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2012-12-31
Completion
2013-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01805466 on ClinicalTrials.gov