CPPF After General Cardiac Surgery (NCT05308589) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of re-exploration
Timeframe: 7 days
Trial details
NCT IDNCT05308589
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)