Miniaturized Extracorporeal Circulation Study

August 6, 2023 updated by: Ivy susanne Modrau, MD, Aarhus University Hospital Skejby

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: CABG with miniaturized ECC
Elective (CABG) with conventional miniaturized extracorporeal circulation (miECC)
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
Procedure: 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
Active Comparator: CABG with conventional ECC
Elective CABG with conventional extracorporeal circulation (cECC)
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
Procedure: Conventional extracorporeal circulation
  • Roller pump
  • Circuit uncoated
  • Hard-shell venous reservoir
  • Intermittend cold blood Harefield cardioplegia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
up to 6 hours after CABG

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative blood loss
Time Frame: up to 24 hours after CABG
Total output of mediastinal and pleural chest tubes
up to 24 hours after CABG
Postoperative transfusion requirement
Time Frame: up to 30 days after CABG
Transfusion of red blood cells, fresh frozen plasma, platelets
up to 30 days after CABG
Fibrinolysis (Clot lysis, Fibrin D-dimer)
Time Frame: up to 24 hours after CABG
Clot lysis measured by dynamic turbidimetry
up to 24 hours after CABG
Coagulation tests
Time Frame: up to 24 hours after CABG
  • Platelet Count
  • aPTT
  • INR
  • Antithrombin
  • Fibrinogen
  • Prothrombin fragment 1+2
up to 24 hours after CABG
Inflammatory response
Time Frame: up to 24 hours after CABG
  • TNF-α
  • Interleukin panel
  • CRP white blood count
up to 24 hours after CABG
Haemodilution (Nadir intraoperative haematocrit)
Time Frame: up to 24 hours after CABG
Measured in arterial blood samples
up to 24 hours after CABG
Haemolysis (LDH)
Time Frame: up to 24 hours postoperative
Measured in lithium heparin plasma
up to 24 hours postoperative
Postoperative CK-MB for myocardial injury
Time Frame: up to 24 hours after CABG
Measured in lithium heparin plasma
up to 24 hours after CABG
-Intraoperative blood lactate for inadequate tissue perfusion
Time Frame: up to 24 hours after CABG
Measured in arterial blood samples
up to 24 hours after CABG
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)
up to 30 days after CABG
-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
48 hours after CABG
-In-hospital neurological events (TCI/stroke)
Time Frame: up to 30 days after CABG
verified by CT or MRI
up to 30 days after CABG
-Postoperative requirement of renal replacement therapy
Time Frame: up to 30 days after CABG
Continuous or intermittend renal replacement therapy
up to 30 days after CABG
-Postoperative re-exploration for bleeding
Time Frame: up to 30 days after CABG
Re-exploration due to excessive bleeding or haemodynamic instability
up to 30 days after CABG
-Repeat revascularization
Time Frame: up to 30 days after CABG
Defined as unplanned repeat PCI or CABG
up to 30 days after CABG
-Length of ICU stay
Time Frame: up to 30 days after CABG
Days of stay on ICU
up to 30 days after CABG
-Duration of inotropic support
Time Frame: up to 30 days after CABG
Hours of pharmacological or mechanical circulatory support
up to 30 days after CABG
-Incidence of atrial fibrillation
Time Frame: up to 30 days after CABG
Documented by telemetry or ECG
up to 30 days after CABG
-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
up to 30 days after CABG
-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%)
24 hours
-30-day MACCE
Time Frame: up to 30 days after CABG
  • Death
  • MI
  • cerebrovascular accident
  • repeat revascularization
up to 30 days after CABG
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)
up to 7 days after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aarhus University Hospital Skejby

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ivy Susanne Modrau, MD, Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-16-02-188-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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