Status:
TERMINATED
CPPF After General Cardiac Surgery
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborating Sponsors:
Haermonics BV
European Regional Development Fund
Conditions:
Cardiac Surgical Procedures
Retained Blood Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 complic...
Detailed Description
CPPF therapy Prolonged or excessive bleeding after cardiac surgery can lead to a broad spectrum of secondary complications. One of the underlying causes is incomplete wound drainage, with subsequent ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 2 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2023
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT05308589
Start Date
November 2 2021
End Date
April 18 2023
Last Update
May 14 2024
Active Locations (4)
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1
Amsterdam UMC
Amsterdam, Netherlands
2
Catharina Ziekenhuis
Eindhoven, Netherlands
3
Leiden University Medical Center
Leiden, Netherlands
4
St. Antonius Ziekenhuis
Nieuwegein, Netherlands