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Miniaturized Extracorporeal Circulation Study

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
CABG
Miniaturized extracorporeal circulation
Conventional extracorporeal circulation
Sponsored by
Aarhus University Hospital Skejby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary artery bypass grafting, Miniaturized extracorporeal circulation, Thrombin generation

Eligibility Criteria

40 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

CABG with miniaturized ECC

CABG with conventional ECC

Arm Description

Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC)

Elective CABG with conventional extracorporeal circulation (cECC)

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
July 8, 2017
Last Updated
August 6, 2023
Sponsor
Aarhus University Hospital Skejby
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1. Study Identification

Unique Protocol Identification Number
NCT03216720
Brief Title
Miniaturized Extracorporeal Circulation Study
Official Title
The Impact of Miniaturized Extracorporeal Circulation on Thrombin Generation and Postoperative Blood Loss
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital Skejby

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary artery bypass grafting, Miniaturized extracorporeal circulation, Thrombin generation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CABG with miniaturized ECC
Arm Type
Active Comparator
Arm Description
Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC)
Arm Title
CABG with conventional ECC
Arm Type
Active Comparator
Arm Description
Elective CABG with conventional extracorporeal circulation (cECC)
Intervention Type
Procedure
Intervention Name(s)
CABG
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Miniaturized extracorporeal circulation
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Conventional extracorporeal circulation
Intervention Description
Roller pump Circuit uncoated Hard-shell venous reservoir Intermittend cold blood Harefield cardioplegia
Primary Outcome Measure Information:
Title
Postoperative thrombin generation
Description
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
Secondary Outcome Measure Information:
Title
Postoperative blood loss
Description
Total output of mediastinal and pleural chest tubes
Time Frame
up to 24 hours after CABG
Title
Postoperative transfusion requirement
Description
Transfusion of red blood cells, fresh frozen plasma, platelets
Time Frame
up to 30 days after CABG
Title
Fibrinolysis (Clot lysis, Fibrin D-dimer)
Description
Clot lysis measured by dynamic turbidimetry
Time Frame
up to 24 hours after CABG
Title
Coagulation tests
Description
Platelet Count aPTT INR Antithrombin Fibrinogen Prothrombin fragment 1+2
Time Frame
up to 24 hours after CABG
Title
Inflammatory response
Description
TNF-α Interleukin panel CRP white blood count
Time Frame
up to 24 hours after CABG
Title
Haemodilution (Nadir intraoperative haematocrit)
Description
Measured in arterial blood samples
Time Frame
up to 24 hours after CABG
Title
Haemolysis (LDH)
Description
Measured in lithium heparin plasma
Time Frame
up to 24 hours postoperative
Title
Postoperative CK-MB for myocardial injury
Description
Measured in lithium heparin plasma
Time Frame
up to 24 hours after CABG
Title
-Intraoperative blood lactate for inadequate tissue perfusion
Description
Measured in arterial blood samples
Time Frame
up to 24 hours after CABG
Title
Postoperative creatinine clearance for renal injury
Description
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
Title
-Perioperative myocardial infarction
Description
defined according to the new definition of clinically relevant MI of the Society for Cardiovascular Angiography and Interventions
Time Frame
48 hours after CABG
Title
-In-hospital neurological events (TCI/stroke)
Description
verified by CT or MRI
Time Frame
up to 30 days after CABG
Title
-Postoperative requirement of renal replacement therapy
Description
Continuous or intermittend renal replacement therapy
Time Frame
up to 30 days after CABG
Title
-Postoperative re-exploration for bleeding
Description
Re-exploration due to excessive bleeding or haemodynamic instability
Time Frame
up to 30 days after CABG
Title
-Repeat revascularization
Description
Defined as unplanned repeat PCI or CABG
Time Frame
up to 30 days after CABG
Title
-Length of ICU stay
Description
Days of stay on ICU
Time Frame
up to 30 days after CABG
Title
-Duration of inotropic support
Description
Hours of pharmacological or mechanical circulatory support
Time Frame
up to 30 days after CABG
Title
-Incidence of atrial fibrillation
Description
Documented by telemetry or ECG
Time Frame
up to 30 days after CABG
Title
-Incidence of infection (requiring antibiotic therapy, wound revision for graft leg infection, superficial or deep sternal wound infection)
Description
Deep sternal wound infection Wound revision for leg harvest surgical site infection Requirement of antibiotic therapy
Time Frame
up to 30 days after CABG
Title
-Feasibility of miECC as measured by conversion to cECC and intraoperative complications
Description
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
Title
-30-day MACCE
Description
Death MI cerebrovascular accident repeat revascularization
Time Frame
up to 30 days after CABG
Title
Acute kidney injury
Description
Association of AKI with Neutrophil gelatinase associated lipocalin (NGAL) and renal risistive index (RRI)
Time Frame
up to 7 days after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivy Susanne Modrau, MD
Organizational Affiliation
Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dep. of Cardiothoracic Surgery, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32011717
Citation
Modrau IS, Halle DR, Nielsen PH, Kimose HH, Greisen JR, Kremke M, Hvas AM. Impact of minimally invasive extracorporeal circulation on coagulation-a randomized trial. Eur J Cardiothorac Surg. 2020 Jun 1;57(6):1145-1153. doi: 10.1093/ejcts/ezaa010.
Results Reference
derived

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Miniaturized Extracorporeal Circulation Study

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