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Continuous Postoperative Pericardial Flush (CPPF); to evaluate the effects of pericardial flush with a crystalloid on blood loss after valvular surgery and correction for congenital heart disease (CHD).


- candidate number22341
- NTR NumberNTR5201
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2015
- Secondary IDsNL42595.018.12 
- Public TitleContinuous Postoperative Pericardial Flush (CPPF); to evaluate the effects of pericardial flush with a crystalloid on blood loss after valvular surgery and correction for congenital heart disease (CHD).
- Scientific TitleContinuous Postoperative Pericardial Flush (CPPF); to evaluate the effects of pericardial flush with a crystalloid on blood loss after valvular surgery and correction for congenital heart disease (CHD).
- ACRONYMCPPF
- hypothesisContinuous postoperative pericardial flush (CPPF) with a crystalloid is likely to enhance the evacuation of activated and contaminated pericardial blood and cloths out of the pericardial cavity and may contribute to a reduction of (excessive) blood loss and here related transfusion requirements and need for re-operation for bleeding after cardiac surgery. Flushing the pericardial cavity is likely to reduce the amount of cloths and old blood remains after removal of the chest tubes and consequently, the incidence of early and late cardiac effusions and tamponade may be reduced.
- Healt Condition(s) or Problem(s) studiedPost operative bleeding problems, Transfusion Triggers
- Inclusion criteriaAll adult patients undergoing surgery for CHD and all adult patients undergoing valvular surgery. Valvular surgery includes single and multiple-valve procedures that involve replacement and/or repair of the aortic-, pulmonary-, mitral- and/or tricuspid valve.
- Exclusion criteriaPatients are not eligible for this study if the following criteria apply:
- Inability to understand study information and/or give informed consent;
- Emergency surgery;
- Indication for treatment with statins based on the CBO-guideline for cardiovascular risk management;
- Myopathia;
- Participation in any study involving an investigational drug or device;
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate11-apr-2017
- Target number of participants170
- InterventionsCPPF will be performed continuously after operation (using a flushing system with a set flow rate of 500ml/hour), starting from the moment the sternum is closed until the total flushing volume of 7000ml has been completely infused.
- Primary outcome1: Mediastinal chest tube drainage (MCTD) 12 hours postoperatively.
2: The difference in hemoglobin levels between the start of CPPF and 12 hours postoperative (ΔHb).
- Secondary outcomeCardiac tamponade, Transfusion requirements, Surgical reexploration, Postoperative atrial fibrillation, sternal wound infection, mediastinitis, Length of ICU stay and hospitalization, Pericardial and/or pleural effusion at discharge, In-hospital mortality, Mortality, Right ventricular function at six months postoperatively
- TimepointsT-1 = Randomization, T0 = Arrival on ICU, T12 = 12 hours postoperatively, T24 = 24 hours postoperatively, TD = Discharge from hospital, T6m = Follow-up six months postoperatively.
- Trial web siteNone
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES Johan S.J. Manshanden
- CONTACT for SCIENTIFIC QUERIES Johan S.J. Manshanden
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-jun-2015 - 9-jul-2017


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