An interventional study of CABG and Miniaturized extracorporeal circulation in Coronary Artery Disease, sponsored by Aarhus University Hospital Skejby. Completed at 1 site in Denmark. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-08-09.
Sponsored by Aarhus University Hospital Skejby · Not applicable, Interventional, and Treatment
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:
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 60 is below the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Aarhus University Hospital Skejby is the lead sponsor of 59 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC)
Procedure: CABG · Procedure: Miniaturized extracorporeal circulation
Elective CABG with conventional extracorporeal circulation (cECC)
Procedure: CABG · Procedure: Conventional extracorporeal circulation
* 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
* 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
* Roller pump * Circuit uncoated * Hard-shell venous reservoir * Intermittend cold blood Harefield cardioplegia
Postoperative thrombin generation
Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram
Time frame: up to 6 hours after CABG
Postoperative blood loss
Total output of mediastinal and pleural chest tubes
Time frame: up to 24 hours after CABG
Postoperative transfusion requirement
Transfusion of red blood cells, fresh frozen plasma, platelets
Time frame: up to 30 days after CABG
Fibrinolysis (Clot lysis, Fibrin D-dimer)
Clot lysis measured by dynamic turbidimetry
Time frame: up to 24 hours after CABG
Coagulation tests
* Platelet Count * aPTT * INR * Antithrombin * Fibrinogen * Prothrombin fragment 1+2
Time frame: up to 24 hours after CABG
Inflammatory response
* TNF-α * Interleukin panel * CRP white blood count
Time frame: up to 24 hours after CABG
Haemodilution (Nadir intraoperative haematocrit)
Measured in arterial blood samples
Time frame: up to 24 hours after CABG
Haemolysis (LDH)
Measured in lithium heparin plasma
Time frame: up to 24 hours postoperative
Postoperative CK-MB for myocardial injury
Measured in lithium heparin plasma
Time frame: up to 24 hours after CABG
-Intraoperative blood lactate for inadequate tissue perfusion
Measured in arterial blood samples
Time frame: up to 24 hours after CABG
Postoperative creatinine clearance for renal injury
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)
Time frame: up to 30 days after CABG
-Perioperative myocardial infarction
defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions
Time frame: 48 hours after CABG
-In-hospital neurological events (TCI/stroke)
verified by CT or MRI
Time frame: up to 30 days after CABG
-Postoperative requirement of renal replacement therapy
Continuous or intermittend renal replacement therapy
Time frame: up to 30 days after CABG
-Postoperative re-exploration for bleeding
Re-exploration due to excessive bleeding or haemodynamic instability
Time frame: up to 30 days after CABG
-Repeat revascularization
Defined as unplanned repeat PCI or CABG
Time frame: up to 30 days after CABG
-Length of ICU stay
Days of stay on ICU
Time frame: up to 30 days after CABG
-Duration of inotropic support
Hours of pharmacological or mechanical circulatory support
Time frame: up to 30 days after CABG
-Incidence of atrial fibrillation
Documented by telemetry or ECG
Time frame: up to 30 days after CABG
-Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection)
* Deep sternal wound infection * Wound revision for leg harvest surgical site infection * Requirement of antibiotic therapy
Time frame: up to 30 days after CABG
-Feasibility of miECC as measured by conversion to cECC and intraoperative complications
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%)
Time frame: 24 hours
-30-day MACCE
* Death * MI * cerebrovascular accident * repeat revascularization
Time frame: up to 30 days after CABG
Acute kidney injury
Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)
Time frame: up to 7 days after intervention
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Plan to share: No
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Aarhus University Hospital Skejby