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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02554305
• Other study ID #: 0033-15-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: August 9, 2015
• Last updated: September 17, 2015
• Start date: October 2015
• Est. completion date: October 2018

Study information

• Verified date: September 2015
• Source: Hadassah Medical Organization
• Contact: Oz Shapira, MD
• Phone: 972-2-6776960
• Email: Ozshapira[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Complication of Coronary Artery Bypass Graft

Intervention

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.
• Affinity oxygenation system
The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	major adverse events	Number of major adverse events (including mortality) will be assessed	Participants will be followed for 30 days following the surgery	Yes
Secondary	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.	Yes
Secondary	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.	Yes
Secondary	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 .	Yes
Secondary	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.	Yes
Secondary	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.	Yes