Miniaturized Extracorporeal Circulation Study

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03216720
• Other study ID #: 1-16-02-188-17
• Status: Completed
• Phase: N/A
• Start date: September 28, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: August 2023
• Source: Aarhus University Hospital Skejby
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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
• 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
• Conventional extracorporeal circulation
Roller pump Circuit uncoated Hard-shell venous reservoir Intermittend cold blood Harefield cardioplegia

Locations

Country	Name	City	State
Denmark	Dep. of Cardiothoracic Surgery, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative thrombin generation	Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram	up to 6 hours after CABG
Secondary	Postoperative blood loss	Total output of mediastinal and pleural chest tubes	up to 24 hours after CABG
Secondary	Postoperative transfusion requirement	Transfusion of red blood cells, fresh frozen plasma, platelets	up to 30 days after CABG
Secondary	Fibrinolysis (Clot lysis, Fibrin D-dimer)	Clot lysis measured by dynamic turbidimetry	up to 24 hours after CABG
Secondary	Coagulation tests	Platelet Count; aPTT; INR; Antithrombin; Fibrinogen; Prothrombin fragment 1+2	up to 24 hours after CABG
Secondary	Inflammatory response	TNF-a; Interleukin panel; CRP white blood count	up to 24 hours after CABG
Secondary	Haemodilution (Nadir intraoperative haematocrit)	Measured in arterial blood samples	up to 24 hours after CABG
Secondary	Haemolysis (LDH)	Measured in lithium heparin plasma	up to 24 hours postoperative
Secondary	Postoperative CK-MB for myocardial injury	Measured in lithium heparin plasma	up to 24 hours after CABG
Secondary	-Intraoperative blood lactate for inadequate tissue perfusion	Measured in arterial blood samples	up to 24 hours after CABG
Secondary	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)	up to 30 days after CABG
Secondary	-Perioperative myocardial infarction	defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions	48 hours after CABG
Secondary	-In-hospital neurological events (TCI/stroke)	verified by CT or MRI	up to 30 days after CABG
Secondary	-Postoperative requirement of renal replacement therapy	Continuous or intermittend renal replacement therapy	up to 30 days after CABG
Secondary	-Postoperative re-exploration for bleeding	Re-exploration due to excessive bleeding or haemodynamic instability	up to 30 days after CABG
Secondary	-Repeat revascularization	Defined as unplanned repeat PCI or CABG	up to 30 days after CABG
Secondary	-Length of ICU stay	Days of stay on ICU	up to 30 days after CABG
Secondary	-Duration of inotropic support	Hours of pharmacological or mechanical circulatory support	up to 30 days after CABG
Secondary	-Incidence of atrial fibrillation	Documented by telemetry or ECG	up to 30 days after CABG
Secondary	-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	up to 30 days after CABG
Secondary	-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%)	24 hours
Secondary	-30-day MACCE	Death; MI; cerebrovascular accident; repeat revascularization	up to 30 days after CABG
Secondary	Acute kidney injury	Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)	up to 7 days after intervention