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Miniaturized Extracorporeal Circulation Study

NCT03216720 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-08-09

No results posted yet for this study

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

Conditions

Interventions

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

PROCEDURE

Conventional extracorporeal circulation

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

Sponsors & Collaborators

  • Aarhus University Hospital Skejby

    lead OTHER

Principal Investigators

  • Ivy Susanne Modrau, MD · Dep. of Cardiothoracic Surgery, Aarhus University Hospital Skejby

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-28
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03216720 on ClinicalTrials.gov