The Fusion Versus The Affinity Oxygenation Systems

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

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.

Study Overview

• Status: Unknown
• Conditions: Complication of Coronary Artery Bypass Graft
• Intervention / Treatment: Device: fusion oxygenation system; Device: Affinity oxygenation system

Detailed 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
• Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
• Patients undergoing elective percutaneous coronary intervention will serve as control groups

Exclusion Criteria:

• Emergency operations
• Left ventricular ejection fraction less than 30%
• CABG with concomitant procedure
• Previous stroke or documented neurological disorder
• High grade (>70%) unilateral or bilateral carotid stenosis
• Contraindication to MRI testing.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fusion oxygenation system; Fusion oxygenation machine will be used during the operation.	Device: fusion oxygenation system; The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.
Active Comparator: Affinity oxygenation system; Affinity oxygenation machine will be used during the operation.	Device: Affinity oxygenation system; The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries
No Intervention: Peripheral vascular procedure; No oxygenation machine will be used in this group
No Intervention: percutaneous coronary intervention; No oxygenation machine will be used in this group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
major adverse events	Number of major adverse events (including mortality) will be assessed	Participants will be followed for 30 days following the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systemic inflammatory response	Serum markers of inflammation will be measured at 4 time points: after induction of anesthesia, immediately after termination of cardiopulmonary bypass, 3 hours, and 3 days postoperatively. : heparinized arterial (intraoperatively) or venous (postoperatively) blood samples will be collected. Bio-assay of endothelial permeability will be also done. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups.	Participants will be followed 3 days following the surgery.
Number of participants with abnormal laboratory values	Hemoglobin and hematocrit, Platelet number and activation and Thrombin activation will be measured. Within each group, the change overtime will be compared to baseline. Participants' number with abnormal laboratory values in each study group will be assessed and compared with the other groups.	Participants will be followed for 3 days following the surgery.
Neurological outcomes-Functional magnetic resonance imaging (MRI)	Changes in brain structure and patterns of neural activation in response to cognitive tasks will be assessed using structural and functional MRI and compared between the study groups.	Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .
Neurological outcomes-Transcranial Doppler (TCD)	Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.	Participants will be followed 3 days following the surgery.
Neurological outcomes- electroencephalogram (EEG)	Changes in brain activity pattern before and after the surgery will be assessed and compared between the study groups.	Participants will be followed 3 days following the surgery.

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Oz Shapira, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: August 9, 2015
• First Submitted That Met QC Criteria: September 17, 2015
• First Posted (Estimate): September 18, 2015

Study Record Updates

• Last Update Posted (Estimate): September 18, 2015
• Last Update Submitted That Met QC Criteria: September 17, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: efficacy and safety of fusion Oxygenation System; isolated Coronary Artery Bypass Grafting; Bypass Grafting
• Other Study ID Numbers: 0033-15-HMO