Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients
MiniCPB
Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery
1 other identifier
interventional
80
1 country
1
Brief Summary
Our intention is to perform a randomized controlled trial to compare the efficacy and safety of mini cardiopulmonary bypass system to a modified conventional bypass circuit in 80 Asian patients undergoing elective CABG. Our intend is to confirm the efficacy of mini-bypass in reducing haemodilution and reducing blood transfusions, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2008
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 1, 2014
CompletedFirst Posted
Study publicly available on registry
September 5, 2018
CompletedSeptember 5, 2018
August 1, 2018
4.7 years
September 1, 2014
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute kidney injury
Meeting AKIN 1 criteria
48 hours after surgery
Secondary Outcomes (2)
Neurocognitive decline
3 months post surgery
Inflammation
72 hours post surgery
Other Outcomes (1)
Atrial fibrillation
7 days post surgery
Study Arms (2)
Mini CPB (ECCO, Sorin, Italy)
ACTIVE COMPARATORUtilization of the mini CPB circuit (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy)
Conventional
PLACEBO COMPARATORUse of conventional CPB circuit
Interventions
Comparison of the mini CPB circuit to conventional circuit
Comparison of the mini CPB circuit to conventional circuit
Eligibility Criteria
You may qualify if:
- first time on pump CABG revascularization
You may not qualify if:
- poor left ventricular ejection faction (\< 30%)
- immunologic disease or malignancies
- acute inflammatory disease
- coagulopathy
- steroid treatment
- preoperative renal failure (currently receiving dialysis)
- significant carotid disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National University Health System
Singapore, 119074, Singapore
Related Publications (1)
Ti LK, Goh BL, Wong PS, Ong P, Goh SG, Lee CN. Comparison of mini-cardiopulmonary bypass system with air-purge device to conventional bypass system. Ann Thorac Surg. 2008 Mar;85(3):994-1000. doi: 10.1016/j.athoracsur.2007.09.001.
PMID: 18291186BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lian K Ti, MBBS, MMed
National University Health System, Singapore
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2014
First Posted
September 5, 2018
Study Start
November 1, 2008
Primary Completion
July 1, 2013
Study Completion
July 1, 2014
Last Updated
September 5, 2018
Record last verified: 2018-08