Miniaturized Extracorporeal Circulation Study

Aarhus University Hospital Skejby

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Procedure: CABG

Procedure: Conventional extracorporeal circulation

Procedure: Miniaturized extracorporeal circulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03216720

1-16-02-188-17

Details and patient eligibility

About

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

Full description

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)

Enrollment

60 patients

Sex

All

Ages

40 to 100 years old

Volunteers

No Healthy Volunteers

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