Miniaturized Extracorporeal Circulation Study
- Conditions
- Coronary Artery Disease
- Interventions
- Procedure: CABGProcedure: Conventional extracorporeal circulationProcedure: Miniaturized extracorporeal circulation
- Registration Number
- NCT03216720
- Lead Sponsor
- Aarhus University Hospital Skejby
- Brief Summary
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
- Detailed 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Non-emergent CABG with ECC
- Current use of low-dose acetylsalicylic acid
- Agreement of eligibility by the multidisciplinary heart team
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CABG with conventional ECC Conventional extracorporeal circulation Elective CABG with conventional extracorporeal circulation (cECC) CABG with conventional ECC CABG Elective CABG with conventional extracorporeal circulation (cECC) CABG with miniaturized ECC CABG Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC) CABG with miniaturized ECC Miniaturized extracorporeal circulation Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC)
- Primary Outcome Measures
Name Time Method Postoperative thrombin generation up to 6 hours after CABG Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram
- Secondary Outcome Measures
Name Time Method Haemodilution (Nadir intraoperative haematocrit) up to 24 hours after CABG Measured in arterial blood samples
Postoperative CK-MB for myocardial injury up to 24 hours after CABG Measured in lithium heparin plasma
-Intraoperative blood lactate for inadequate tissue perfusion up to 24 hours after CABG Measured in arterial blood samples
Postoperative blood loss up to 24 hours after CABG Total output of mediastinal and pleural chest tubes
-In-hospital neurological events (TCI/stroke) up to 30 days after CABG verified by CT or MRI
-Postoperative requirement of renal replacement therapy up to 30 days after CABG Continuous or intermittend renal replacement therapy
-Length of ICU stay up to 30 days after CABG Days of stay on ICU
-Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection) up to 30 days after CABG * Deep sternal wound infection
* Wound revision for leg harvest surgical site infection
* Requirement of antibiotic therapyPostoperative transfusion requirement up to 30 days after CABG Transfusion of red blood cells, fresh frozen plasma, platelets
Inflammatory response up to 24 hours after CABG * TNF-α
* Interleukin panel
* CRP white blood countHaemolysis (LDH) up to 24 hours postoperative Measured in lithium heparin plasma
Fibrinolysis (Clot lysis, Fibrin D-dimer) up to 24 hours after CABG Clot lysis measured by dynamic turbidimetry
Coagulation tests up to 24 hours after CABG * Platelet Count
* aPTT
* INR
* Antithrombin
* Fibrinogen
* Prothrombin fragment 1+2Postoperative creatinine clearance for renal injury up to 30 days after CABG Creatinine measured in lithium heparin plasma. eGFR calculated according to the CKD EPI Equation for Estimating GFR Expressed for Specified Race, Sex and Serum Creatinine (µmol/L)
-Perioperative myocardial infarction 48 hours after CABG defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions
-Duration of inotropic support up to 30 days after CABG Hours of pharmacological or mechanical circulatory support
-Postoperative re-exploration for bleeding up to 30 days after CABG Re-exploration due to excessive bleeding or haemodynamic instability
-Repeat revascularization up to 30 days after CABG Defined as unplanned repeat PCI or CABG
-Incidence of atrial fibrillation up to 30 days after CABG Documented by telemetry or ECG
-Feasibility of miECC as measured by conversion to cECC and intraoperative complications 24 hours Serious adverse device events (air lock, dissection, bleeding that exceeds the capacity of the cell saver, air emboli, stop of the circuit, conversion to cECC)
- technical aspects (postoperative fluid gain (ml), venous drainage, visibility due to blood in the operative field, ability to maintain SvO2 \>65%)-30-day MACCE up to 30 days after CABG * Death
* MI
* cerebrovascular accident
* repeat revascularizationAcute kidney injury up to 7 days after intervention Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)
Trial Locations
- Locations (1)
Dep. of Cardiothoracic Surgery, Aarhus University Hospital
🇩🇰Aarhus, Denmark