Continuous 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…
ID
Bron
Verkorte titel
Aandoening
Postoperative blood loss, Cardiac tamponade, Transfusion requirements, Health-related quality of life, Cost-effectiveness.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1: Mediastinal chest tube drainage (MCTD) at 12 hours postoperatively. <br>
2: The difference in haemoglobin levels between the start of CPPF and 12 hours postoperative (ΔHb).
Doel van het onderzoek
Continuous 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.
Onderzoeksopzet
T-1 = Randomization. T0 = Arrival on ICU. T12 = 12 hours postoperatively. T24 = 24 hours postoperatively. TD = Discharge from hospital. T6m = Follow-up 6 months postoperatively.
Onderzoeksproduct en/of interventie
CPPF 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.
Publiek
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Wetenschappelijk
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All adult patients (>18y) undergoing surgery for CABG.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients 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;
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5069 |
| NTR-old | NTR5200 |
| CCMO | NL43190.018.13 |
| OMON | NL-OMON44986 |