No registrations found.
ID
Source
Brief title
Health condition
Postoperative blood loss, Cardiac tamponade, Transfusion requirements, Health-related quality of life, Cost-effectiveness.
Sponsors and support
Intervention
Outcome measures
Primary outcome
1: 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 outcome
Cardiac 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.
Study objective
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.
Study design
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.
Intervention
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.
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Johan S.J. Manshanden
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
T +31 (0) 20 - 566 81 88
j.s.manshanden@amc.uva.nl
Inclusion criteria
All adult patients (>18y) undergoing surgery for CABG.
Exclusion criteria
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;
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5069 |
| NTR-old | NTR5200 |
| CCMO | NL43190.018.13 |
| OMON | NL-OMON44986 |