NCT03216720

Miniaturized Extracorporeal Circulation Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Aarhus University Hospital Skejby · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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

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)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-28
• Primary completion: 2018-11-30
• Completion: 2018-11-30
• First posted: 2017-07-13
• Last updated: 2023-08-09

Locations

1 site across 1 country: Denmark