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Continuous Postoperative Pericardial Flush; to evaluate the effects of pericardial flush with a crystalloid on blood loss after CABG.


- candidate number22340
- NTR NumberNTR5200
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jun-2015
- Secondary IDsNL43190.018.13 
- Public TitleContinuous Postoperative Pericardial Flush; to evaluate the effects of pericardial flush with a crystalloid on blood loss after CABG.
- Scientific TitleContinuous Postoperative Pericardial Flush; to evaluate the effects of pericardial flush with a crystalloid on blood loss after CABG.
- 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 CABG. 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, Quality of life, Cost-effectiveness
- Inclusion criteriaAll adult patients (>18y) undergoing surgery for CABG.
- Exclusion criteriaPatients are not eligible for this study if the following criteria apply:
- Previous CABG;
- Emergency surgery;
- Preoperative use of Dabigatran, Rivaroxaban, Apixaban, Clopidogrel, Brilique or Prasugrel;
- <18 years and/or inability to understand study information / give informed consent;
- Participation in any study involving an investigational drug or device;
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2014
- planned closingdate31-dec-2015
- 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) at 12 hours postoperatively.
2: The difference in haemoglobin 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, In-hospital mortality, Hemoglobin at discharge, Pericardial and/or pleural effusion at discharge, Mortality, Right ventricular function six months postoperatively, Quality of life (EQ-5D+) six months postoperatively, Health and labour questionnaire (SF-HLQ) six months postoperatively, cost effectiveness.
- TimepointsT-1 = Randomization. T0 = Arrival on ICU. T12 = 12 hours postoperatively. T24 = 24 hours postoperatively. TD = Discharge from hospital. T6m = Follow-up 6 months postoperatively.
- Trial web sitenone
- statusopen: patient inclusion
- 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)
ZonMw DoelmatigheidsOnderzoek Type I Program
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD14-jun-2015 - 25-jul-2015


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