Miniaturized Extracorporeal Circulation Study

The Impact of Miniaturized Extracorporeal Circulation on Thrombin Generation and Postoperative Blood Loss

Rationale:

Contemporary coronary artery bypass grafting (CABG) continues to be associated with a significant risk of postoperative bleeding. Utilization of miniaturized extracorporeal circulation (miECC) significantly reduces the risk of postoperative bleeding but the underlying mechanisms are poorly understood.

Primary Objective:

To assess the impact of miECC compared to conventional extracorporeal circulation (cECC) on thrombin generation as indicator of the overall haemostatic capacity after CABG.

Secondary Objectives To evaluate the impact of miECC versus cECC on blood loss and transfusion requirement, coagulation and fbrinolysis, inflammatory response, haemodilution and haemolysis, endorgan protection, seasibility and safety

Study design:

Single-center, double-blind, parallel-group randomized controlled trial

Study population:

60 Patients undergoing non-emergent primary isolated CABG with ECC randomized 1:1 to receive either miECC or cECC

Blood samples will be obtained at the following time points:

• T0; preoperative after induction of anaesthesia (after insertion of central venous line)
• T1; after weaning of the ECC prior to protaminization
• T2; 10 minutes after full protaminization
• T3; six hours after the end of the ECC
• T4; 1. postoperative day (16-20 hours following end of surgery)

Inclusion Criteria:

• Non-emergent CABG with ECC
• Current use of low-dose acetylsalicylic acid
• Agreement of eligibility by the multidisciplinary heart team

Exclusion Criteria:

• Inability to give informed consent
• Emergent treatment required (< 24 hours)
• Concomitant cardiac surgery
• Previous cardiac surgery
• Severely reduced kidney function (eGFR < 30ml/min/1.73m2 or on dialysis)
• Severely reduced ejection fraction (EF < 45%)
• Diagnosis of bleeding disorders
• Non-aspirin antiplatelet drugs stopped < 5 days preoperatively (Clopidogrel, Prasugrel, Ticagrelor, Ticlopidine)
• Current use of systemic glucocorticoid therapy
• Current use of vitamin K antagonists or new oral non-vitamin K anticoagulants
• Platelet count > 450 or <100 x 109/l prior to surgery
• Pregnant women or women of child bearing potential without negative pregnancy test
• Active participant in any other intervention trial