Trials / Unknown
UnknownNCT02554305
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)
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hadassah Medical Organization · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| DEVICE | Affinity oxygenation system | The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2017-10-01
- Completion
- 2018-10-01
- First posted
- 2015-09-18
- Last updated
- 2015-09-18
Source: ClinicalTrials.gov record NCT02554305. Inclusion in this directory is not an endorsement.