Target Activated Clotting time for anticoagulation during cardiopulmonary bypass
- Conditions
- Heart diseases
- Registration Number
- NL-OMON27592
- Lead Sponsor
- niversity Medical Center Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1536
• 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
• 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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Packed red blood cell (PRBC) transfusion rates during hospitalization
- Secondary Outcome Measures
Name Time Method • 12 and 24-hour blood loss assessed by wound drainage<br> • Postoperative hemoglobin values at 1, 12 and 24 hours following surgery<br> • Reoperations due to bleeding<br> • Late tamponade<br> • Transfusion requirements (FFP, platelets, fibrinogen, PCC)<br> • Postoperative hemostatic parameters<br> • Use of preoperative anticoagulant medication <br> • Number of patients who do not reach the target ACT after the first heparin dose<br> • Total heparin and protamine dosing<br> • Postoperative restenosis of grafts<br> • Clotting of the extracorporeal circuit<br> • Thromboembolic events during and following surgery <br> • Mortality at 30 days, 90 days and 1 year following surgery<br> • Patient demographics