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Completed

NCT Number: NCT03216720

Miniaturized Extracorporeal Circulation Study

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CABG

Procedure
  • 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

Procedure
  • 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

Procedure
  • Roller pump
  • Circuit uncoated
  • Hard-shell venous reservoir
  • Intermittend cold blood Harefield cardioplegia

Primary outcomes

  1. Postoperative thrombin generation

    Time frame: 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 outcomes

  1. Postoperative blood loss

    Time frame: up to 24 hours after CABG

    Total output of mediastinal and pleural chest tubes

  2. Postoperative transfusion requirement

    Time frame: up to 30 days after CABG

    Transfusion of red blood cells, fresh frozen plasma, platelets

  3. Fibrinolysis (Clot lysis, Fibrin D-dimer)

    Time frame: up to 24 hours after CABG

    Clot lysis measured by dynamic turbidimetry

  4. Coagulation tests

    Time frame: up to 24 hours after CABG

    • Platelet Count
    • aPTT
    • INR
    • Antithrombin
    • Fibrinogen
    • Prothrombin fragment 1+2

  5. Inflammatory response

    Time frame: up to 24 hours after CABG

    • TNF-α
    • Interleukin panel
    • CRP white blood count

  6. Haemodilution (Nadir intraoperative haematocrit)

    Time frame: up to 24 hours after CABG

    Measured in arterial blood samples

  7. Haemolysis (LDH)

    Time frame: up to 24 hours postoperative

    Measured in lithium heparin plasma

  8. Postoperative CK-MB for myocardial injury

    Time frame: up to 24 hours after CABG

    Measured in lithium heparin plasma

  9. -Intraoperative blood lactate for inadequate tissue perfusion

    Time frame: up to 24 hours after CABG

    Measured in arterial blood samples

  10. Postoperative creatinine clearance for renal injury

    Time frame: 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)

  11. -Perioperative myocardial infarction

    Time frame: 48 hours after CABG

    defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions

  12. -In-hospital neurological events (TCI/stroke)

    Time frame: up to 30 days after CABG

    verified by CT or MRI

  13. -Postoperative requirement of renal replacement therapy

    Time frame: up to 30 days after CABG

    Continuous or intermittend renal replacement therapy

  14. -Postoperative re-exploration for bleeding

    Time frame: up to 30 days after CABG

    Re-exploration due to excessive bleeding or haemodynamic instability

  15. -Repeat revascularization

    Time frame: up to 30 days after CABG

    Defined as unplanned repeat PCI or CABG

  16. -Length of ICU stay

    Time frame: up to 30 days after CABG

    Days of stay on ICU

  17. -Duration of inotropic support

    Time frame: up to 30 days after CABG

    Hours of pharmacological or mechanical circulatory support

  18. -Incidence of atrial fibrillation

    Time frame: up to 30 days after CABG

    Documented by telemetry or ECG

  19. -Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection)

    Time frame: up to 30 days after CABG

    • Deep sternal wound infection
    • Wound revision for leg harvest surgical site infection
    • Requirement of antibiotic therapy

  20. -Feasibility of miECC as measured by conversion to cECC and intraoperative complications

    Time frame: 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%)

  21. -30-day MACCE

    Time frame: up to 30 days after CABG

    • Death
    • MI
    • cerebrovascular accident
    • repeat revascularization

  22. Acute kidney injury

    Time frame: up to 7 days after intervention

    Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)

Sponsors and collaborators

Lead sponsor

Aarhus University Hospital Skejby

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 13, 2017
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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