Miniaturized Extracorporeal Circulation Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• 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)

Study Timeline

• Study First Submitted: 2017-07-08
• Study First Submitted QC: 2017-07-11
• Study First Posted: 2017-07-13
• Study Start: 2017-09-28
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-06
• Last Update Posted: 2023-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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
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
-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
Postoperative 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 count
Haemolysis (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+2
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 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
-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 revascularization
Acute kidney injury	up to 7 days after intervention	Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)
-Length of ICU stay	up to 30 days after CABG	Days of stay on ICU
-Repeat revascularization	up to 30 days after CABG	Defined as unplanned repeat PCI or CABG

Trial Locations

Locations (1)

Dep. of Cardiothoracic Surgery, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark