TerminatedNot Applicable

CPPF After General Cardiac Surgery

Stopped: The study no longer fits our strategic goals. The preliminary results of FLUID have led to an improved version of the current device. We believe it is necessary to initiate a new study, with the improved version of the device.

Netherlands164 participantsStarted 2021-11-02

Plain-language summary

In two randomized clinical trials the investigators have demonstrated that continuous postoperative pericardial flushing (CPPF) therapy can reduce postoperative blood loss and bleeding-related complications after cardiac surgery and that CPPF therapy is safe and feasible in an experimental setting. The Haermonics investigational device is a novel medical device that enables CPPF therapy to be used in daily clinical setting. The aim of this study is three-fold. First, to evaluate the safety and functionality of the Haermonics investigational device. Secondly, to investigate the effect of CPPF therapy on bleeding related complications in the adulty cardiac surgery population. Thirdly, to explore the effect of CPPF therapy on intraluminal chest tube clogging.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: In order to be eligible to participate in this study, a subject should be scheduled for a general cardiothoracic surgery procedure with the use of cardiopulmonary bypass, amongst others, the main categories are; * Coronary artery bypass grafting (CABG), * Valve surgery, * CABG combined with valve surgery * Elective patients scheduled for aortic surgery (including valve sparing root replacement (VSRR), Bentall procedures, ascending aorta- aortic arch replacement) Including the initial study population: * Patients scheduled for CABG with continued DAPT * Patients with aIE scheduled for valve replacement * Patients scheduled for complex or multiple cardiac (redo) procedures with an (expected) CPB time \>300 minutes * Patients undergoing aortic surgery with DHCA Exclusion Criteria: * Euroscore II \> 20% * Intraoperatively diaphragm injury leading to an open connection between the thoracic and abdominal cavity * Age \< 18 * Inability to understand study information * Participation in any study involving an investigational drug or device * Emergent procedures * Procedures performed off pump, without the use of cardiopulmonary bypass. * Minimal invasive cardiac surgery procedures (e.g. minithoracotomy and hemisternotomy)

What they're measuring

Incidence of re-exploration

Timeframe: 7 days

Trial details

NCT IDNCT05308589

SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-18