The Fusion Versus The Affinity Oxygenation Systems

Complication of Coronary Artery Bypass Graft Clinical Trial

Official title: The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)

Status Not yet recruiting

Clinical Trial Summary

This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.

Clinical Trial Description

In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Complication of Coronary Artery Bypass Graft

• NCT number: NCT02554305
• Study type: Interventional
• Source: Hadassah Medical Organization
• Contact: Oz Shapira, MD
• Phone: 972-2-6776960
• Email: Ozshapira@hadassah.org.il
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2015
• Completion date: October 2018