Miniaturized Extracorporeal Circulation Study
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CABG with miniaturized ECC Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC) |
Procedure: CABG
Cannulation: 24-F arterial cannula, 29/29 F dual-stage venous cannula, and aortic root vent-/cardioplegia cannula
Grafting: pedicled left internal mammary artery, and no-touch
saphenous vein graft Heparin and protamine doses assessed by HMS Plus® Hemostasis Management System
Target activated coagulation time of >400 seconds
Procedure: Miniaturized extracorporeal circulation
Centrifugal pump to reduce mechanical stress
Circuit coated with biosurface to increase haemocompatibilty.
Ante- and retrograde autologous priming and low-volume cardioplegia solution (intermittend cold modified Calafiore) to minimize haemodilution
Collapsible soft-shell reservoir for blood volume management
Cell-saving device
Venous air removing device and electric clamp system to air embolism
|
| Active Comparator: CABG with conventional ECC Elective CABG with conventional extracorporeal circulation (cECC) |
Procedure: CABG
Cannulation: 24-F arterial cannula, 29/29 F dual-stage venous cannula, and aortic root vent-/cardioplegia cannula
Grafting: pedicled left internal mammary artery, and no-touch
saphenous vein graft Heparin and protamine doses assessed by HMS Plus® Hemostasis Management System
Target activated coagulation time of >400 seconds
Procedure: Conventional extracorporeal circulation
Roller pump
Circuit uncoated
Hard-shell venous reservoir
Intermittend cold blood Harefield cardioplegia
|
Outcome Measures
Primary Outcome Measures
- 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
- Postoperative blood loss [up to 24 hours after CABG]
Total output of mediastinal and pleural chest tubes
- Postoperative transfusion requirement [up to 30 days after CABG]
Transfusion of red blood cells, fresh frozen plasma, platelets
- 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+2
- Inflammatory response [up to 24 hours after CABG]
TNF-α Interleukin panel CRP white blood count
- Haemodilution (Nadir intraoperative haematocrit) [up to 24 hours after CABG]
Measured in arterial blood samples
- Haemolysis (LDH) [up to 24 hours postoperative]
Measured in lithium heparin plasma
- 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 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
- -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
- -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
- -Length of ICU stay [up to 30 days after CABG]
Days of stay on ICU
- -Duration of inotropic support [up to 30 days after CABG]
Hours of pharmacological or mechanical circulatory support
- -Incidence of atrial fibrillation [up to 30 days after CABG]
Documented by telemetry or ECG
- -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 therapy
- -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 revascularization
- Acute kidney injury [up to 7 days after intervention]
Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Dep. of Cardiothoracic Surgery, Aarhus University Hospital | Aarhus | Denmark | 8200 |
Sponsors and Collaborators
- Aarhus University Hospital Skejby
Investigators
- Principal Investigator: Ivy Susanne Modrau, MD, Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby
Study Documents (Full-Text)
More Information
Publications
None provided.- 1-16-02-188-17