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Clinical 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.

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


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03216720
Study type Interventional
Source Aarhus University Hospital Skejby
Contact Ivy Susanne Modrau, MD
Phone +45 24778856
Email ivy.modrau@skejby.rm.dk
Status Recruiting
Phase N/A
Start date September 28, 2017
Completion date January 2019

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