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Coronary Artery DiseaseNCT03216720

Miniaturized Extracorporeal Circulation Study

A study testing CABG, Miniaturized extracorporeal circulation and Conventional extracorporeal circulation in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 to 100 years
Conditions the study is for
Coronary Artery Disease
What is being tested?
CABG, Miniaturized extracorporeal circulation and Conventional extracorporeal circulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteDenmark
Study dates
28 Sep 2017to 30 Nov 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Non-emergent CABG with ECC
  • Current use of low-dose acetylsalicylic acid
  • Agreement of eligibility by the multidisciplinary heart team

Who cannot join

  • 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%)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Dep. of Cardiothoracic Surgery, Aarhus University Hospital

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: 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.

Read more

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

Read the 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)
Being tested
CABG, Miniaturized extracorporeal circulation, Conventional extracorporeal circulation
Keywords
Coronary artery bypass grafting, Miniaturized extracorporeal circulation, Thrombin generation
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CABGProcedure or surgery

    • 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 circulationProcedure or surgery

    • 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 circulationProcedure or surgery

    • Roller pump
    • Circuit uncoated
    • Hard-shell venous reservoir
    • Intermittend cold blood Harefield cardioplegia
Study groups in NCT03216720
Study groupRoleWhat they receive
CABG with miniaturized ECCActive comparatorElective (CABG) with conventional miniaturized extracorporeal circulation (miECC)
Receives: Procedure: CABG; Procedure: Miniaturized extracorporeal circulation
CABG with conventional ECCActive comparatorElective CABG with conventional extracorporeal circulation (cECC)
Receives: Procedure: CABG; Procedure: Conventional extracorporeal circulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative thrombin generation

    Thrombin generation as a measure of the ability to generate thrombin in platelet poor plasma. Derived from the thrombogram

    Measured: up to 6 hours after CABG

Secondary outcomes (22)

  1. Postoperative blood loss

    Total output of mediastinal and pleural chest tubes

    Measured: up to 24 hours after CABG

  2. Postoperative transfusion requirement

    Transfusion of red blood cells, fresh frozen plasma, platelets

    Measured: up to 30 days after CABG

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

    Clot lysis measured by dynamic turbidimetry

    Measured: up to 24 hours after CABG

  4. Coagulation tests

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

    Measured: up to 24 hours after CABG

  5. Inflammatory response

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

    Measured: up to 24 hours after CABG

  6. Haemodilution (Nadir intraoperative haematocrit)

    Measured in arterial blood samples

    Measured: up to 24 hours after CABG

  7. Haemolysis (LDH)

    Measured in lithium heparin plasma

    Measured: up to 24 hours postoperative

  8. Postoperative CK-MB for myocardial injury

    Measured in lithium heparin plasma

    Measured: up to 24 hours after CABG

  9. -Intraoperative blood lactate for inadequate tissue perfusion

    Measured in arterial blood samples

    Measured: up to 24 hours after CABG

  10. 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)

    Measured: up to 30 days after CABG

  11. -Perioperative myocardial infarction

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

    Measured: 48 hours after CABG

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

    verified by CT or MRI

    Measured: up to 30 days after CABG

  13. -Postoperative requirement of renal replacement therapy

    Continuous or intermittend renal replacement therapy

    Measured: up to 30 days after CABG

  14. -Postoperative re-exploration for bleeding

    Re-exploration due to excessive bleeding or haemodynamic instability

    Measured: up to 30 days after CABG

  15. -Repeat revascularization

    Defined as unplanned repeat PCI or CABG

    Measured: up to 30 days after CABG

  16. -Length of ICU stay

    Days of stay on ICU

    Measured: up to 30 days after CABG

  17. -Duration of inotropic support

    Hours of pharmacological or mechanical circulatory support

    Measured: up to 30 days after CABG

  18. -Incidence of atrial fibrillation

    Documented by telemetry or ECG

    Measured: up to 30 days after CABG

  19. -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

    Measured: up to 30 days after CABG

  20. -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%)

    Measured: 24 hours

  21. -30-day MACCE

    • Death
    • MI
    • cerebrovascular accident
    • repeat revascularization

    Measured: up to 30 days after CABG

  22. Acute kidney injury

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

    Measured: up to 7 days after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study start28 Sep 2017
  3. Primary completion30 Nov 2018
  4. Study completion30 Nov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216720
Sponsor's protocol ID
1-16-02-188-17
Status last verified
Aug 2023
First submitted
8 Jul 2017
Last updated
9 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Halle DR, Benhassen LL, Soberg KL, Nielsen PF, Kimose HH, Bauer A, Hasenkam JM, Modrau IS. Impact of minimal invasive extracorporeal circulation on systemic inflammatory response - a randomized trial. J Cardiothorac Surg. 2024 Jul 3;19(1):418. doi: 10.1186/s13019-024-02903-8.

    PubMed 38961388

  • 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.

    PubMed 32011717

Questions about this trial

What is this clinical trial studying?

A study testing CABG, Miniaturized extracorporeal circulation and Conventional extracorporeal circulation in people with Coronary Artery Disease, run by Aarhus University Hospital Skejby at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative thrombin generation (time frame: up to 6 hours after CABG). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216720, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.

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Miniaturized Extracorporeal Circulation Study | AzTrials