NCT03216720

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 13, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

August 9, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

July 8, 2017

Last Update Submit

August 6, 2023

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass graftingMiniaturized extracorporeal circulationThrombin generation

Outcome Measures

Primary Outcomes (1)

  • Postoperative thrombin generation

    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 Outcomes (22)

  • Postoperative blood loss

    up to 24 hours after CABG

  • Postoperative transfusion requirement

    up to 30 days after CABG

  • Fibrinolysis (Clot lysis, Fibrin D-dimer)

    up to 24 hours after CABG

  • Coagulation tests

    up to 24 hours after CABG

  • Inflammatory response

    up to 24 hours after CABG

  • +17 more secondary outcomes

Study Arms (2)

CABG with miniaturized ECC

ACTIVE COMPARATOR

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

Procedure: CABGProcedure: Miniaturized extracorporeal circulation

CABG with conventional ECC

ACTIVE COMPARATOR

Elective CABG with conventional extracorporeal circulation (cECC)

Procedure: CABGProcedure: Conventional extracorporeal circulation

Interventions

CABGPROCEDURE

* 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

CABG with conventional ECCCABG with miniaturized ECC
Miniaturized extracorporeal circulationPROCEDURE

* 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

CABG with miniaturized ECC
Conventional extracorporeal circulationPROCEDURE

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

CABG with conventional ECC

Eligibility Criteria

Age40 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dep. of Cardiothoracic Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Related Publications (2)

  • 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.

    PMID: 38961388DERIVED

  • 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.

    PMID: 32011717DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Ivy Susanne Modrau, MD

    Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Cardiac Surgeon, Associate Professor

Study Record Dates

First Submitted

July 8, 2017

First Posted

July 13, 2017

Study Start

September 28, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

August 9, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)