Miniaturized Extracorporeal Circulation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-28

Study Completion Date

2018-11-30

Brief Summary

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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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Detailed Description

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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)

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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CABG with miniaturized ECC

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

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type 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

Intervention Type 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

CABG with conventional ECC

Elective CABG with conventional extracorporeal circulation (cECC)

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type 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

Conventional extracorporeal circulation

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Conventional extracorporeal circulation

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No