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

NACompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

December 31, 2012

Study Completion Date

July 31, 2013

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

Trial Locations (4)

48010

Maria Cecilia Hospital, Cotignola

Unknown

Anthea Hospital, Bari

Città di Lecce Hospital, Lecce

ICLAS Rapallo, Rapallo

All Listed Sponsors
collaborator

Ettore Sansavini Health Science Foundation

OTHER

lead

IRCCS San Raffaele Roma

OTHER

NCT01805466 - Effects on Organ Damage and Surgical Outcome of a New Cardiopulmonary Pass System (EVADO) | Biotech Hunter | Biotech Hunter