Clinical trial NCT02554305: The Fusion Versus The Affinity Oxygenation Systems
Official title: The Fusion Versus The Affinity Oxygenation Systems - A Prospective Randomized Trial In Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complication of Coronary Artery Bypass Graft
Keywords: efficacy and safety of fusion Oxygenation System
isolated Coronary Artery Bypass Grafting
Bypass Grafting
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: major adverse events
timeFrame: Participants will be followed for 30 days following the surgery
Secondary outcomes:
measure: Systemic inflammatory response
timeFrame: Participants will be followed 3 days following the surgery.
measure: Number of participants with abnormal laboratory values
timeFrame: Participants will be followed for 3 days following the surgery.
measure: Neurological outcomes-Functional magnetic resonance imaging (MRI)
timeFrame: Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .
measure: Neurological outcomes-Transcranial Doppler (TCD)
timeFrame: Participants will be followed 3 days following the surgery.
measure: Neurological outcomes- electroencephalogram (EEG)
timeFrame: Participants will be followed 3 days following the surgery.
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Oz Shapira, MD
role: PRINCIPAL_INVESTIGATOR
References: