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ID
Source
Brief title
Health condition
Heart diseases
Sponsors and support
Intervention
Outcome measures
Primary outcome
Packed red blood cell (PRBC) transfusion rates during hospitalization
Secondary outcome
• 12 and 24-hour blood loss assessed by wound drainage
• Postoperative hemoglobin values at 1, 12 and 24 hours following surgery
• Reoperations due to bleeding
• Late tamponade
• Transfusion requirements (FFP, platelets, fibrinogen, PCC)
• Postoperative hemostatic parameters
• Use of preoperative anticoagulant medication
• Number of patients who do not reach the target ACT after the first heparin dose
• Total heparin and protamine dosing
• Postoperative restenosis of grafts
• Clotting of the extracorporeal circuit
• Thromboembolic events during and following surgery
• Mortality at 30 days, 90 days and 1 year following surgery
• Patient demographics
Background summary
Patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) require full anticoagulation to inhibit thrombin production, reduce clot formation and activation of the coagulation system. Worldwide, but also in the Netherlands, various target activated clotting time (ACT) values are used during CPB. While part of the centers use a target ACT > 480 seconds, others use an ACT > 400 seconds. Due to the lack of large randomized controlled trials in modern cardiosurgical settings it is unclear which target ACT is associated with the most favorable hemostatic profile following cardiac surgery. The present study therefore aims to investigate the impact of a minimal target ACT of 400 or 480 seconds, respectively, on transfusion rates, postoperative blood loss and reoperations in patients undergoing cardiac surgery with cardiopulmonary bypass.
Study objective
It is hypothesized that anticoagulation with a target ACT > 400 seconds is equivalent to a target ACT > 480 seconds with respect to packed red blood cell (PRBC) transfusion rates during hospitalization in patients undergoing cardiac surgery with cardiopulmonary bypass.
Study design
N/A
Intervention
Heparin anticoagulation during cardiopulmonary bypass with a target ACT of 400 seconds versus a target ACT of 480 seconds
Inclusion criteria
• Patients scheduled for elective CABG or cardiac valve surgery, or a combination of CABG with valve surgery, or (cross-clamped) aortic root or ascendens procedures with cardiopulmonary bypass.
• Adult surgery
• Informed consent
Exclusion criteria
• Re-operations
• Aorta surgery (requiring SCP and/or circulatory arrest)
• Emergency operation
• Minimized extracorporeal circuits (MECC)
• Deep hypothermia (<32oC)
• Patients with congenital coagulation factor abnormalities (e.g. von Willebrand disease, hemophilia)
• Patients with acquired coagulation factor abnormalities (e.g. acquired haemophilia, acquired von Willebrand disease, haematological malignities, thrombocytopenia <75*109/L)
• Patients with anemia (hemoglobin value < 6.5 mmol/l)
Design
Recruitment
IPD sharing statement
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 | NL7575 |
| CCMO | NL64741.041.18 |
| OMON | NL-OMON52711 |