NCT02554305

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 18, 2015

Completed
13 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

2 years

First QC Date

August 9, 2015

Last Update Submit

September 17, 2015

Conditions

Complication of Coronary Artery Bypass Graft

Keywords

efficacy and safety of fusion Oxygenation Systemisolated Coronary Artery Bypass GraftingBypass Grafting

Outcome Measures

Primary Outcomes (1)

  • major adverse events

    Number of major adverse events (including mortality) will be assessed

    Participants will be followed for 30 days following the surgery

Secondary Outcomes (5)

  • Systemic inflammatory response

    Participants will be followed 3 days following the surgery.

  • Number of participants with abnormal laboratory values

    Participants will be followed for 3 days following the surgery.

  • Neurological outcomes-Functional magnetic resonance imaging (MRI)

    Changes in brain activity pattern will be assessed at baseline and 4 weeks postoperatively .

  • Neurological outcomes-Transcranial Doppler (TCD)

    Participants will be followed 3 days following the surgery.

  • Neurological outcomes- electroencephalogram (EEG)

    Participants will be followed 3 days following the surgery.

Study Arms (4)

Fusion oxygenation system

ACTIVE COMPARATOR

Fusion oxygenation machine will be used during the operation.

Device: fusion oxygenation system

Affinity oxygenation system

ACTIVE COMPARATOR

Affinity oxygenation machine will be used during the operation.

Device: Affinity oxygenation system

Peripheral vascular procedure

NO INTERVENTION

No oxygenation machine will be used in this group

percutaneous coronary intervention

NO INTERVENTION

No oxygenation machine will be used in this group

Interventions

fusion oxygenation systemDEVICE

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.

Fusion oxygenation system
Affinity oxygenation systemDEVICE

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

Affinity oxygenation system

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Oz Shapira, MD

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oz Shapira, MD

CONTACT

972-2-6776960Ozshapira@hadassah.org.il

Hadas Lemberg, PhD

CONTACT

972- 2- 6777572lhadas@hadassah.org.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DIRECTOR OF THE DEPARTMENT OF CARDIOTHORACIC SURGERY

Study Record Dates

First Submitted

August 9, 2015

First Posted

September 18, 2015

Study Start

October 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2018

Last Updated

September 18, 2015

Record last verified: 2015-09