Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients

NCT ID: NCT03657225

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2014-07-31

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.

Detailed Description

Mini-bypass systems have the potential to reduce the problems associated with conventional cardiopulmonary bypass systems by preserving hematocrit, reducing transfusion requirements, and reducing inflammation. Intuitively, this system would be ideal for our smaller Asian patients, who as a result of their body sizes, are prone to severe hemodilution and increased transfusion requirements. However, our initial results based on established Western protocols were not as good as the investigators hoped. Using a modified protocol, the investigators were able to reduce perioperative blood transfusion. Therefore, the investigators intend to prospectively confirm the efficacy of mini-bypass in conjunction with our modified protocol in reducing haemodilution and reducing blood transfusions. The investigators will also establish the safety of this protocol, and investigate if this is associated with reduced inflammation and better cardiovascular, neurological, renal, respiratory and infection outcomes.

80 Asian patients undergoing primary coronary artery bypass grafting with cardiopulmonary bypass will be randomly divided either to utilize the mini-bypass system (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy) or the conventional system. Anaesthesia, surgical and perfusion management will be standardized, except for measures specific to the establishment of mini-bypass. The primary outcome measures will be haemodilution (first and lowest hematocrit) during cardiopulmonary bypass, blood loss in the first 24 and 48 hours post-operatively, and perioperative blood transfusions. Secondary outcomes include safety profile (air embolization, hypoperfusion), inflammation (TNF-alpha, interleukin-6, C-reactive protein, lactate dehydrogenase) in the first 72 hours after bypass, clinical outcomes (renal, neurological, cardiac, respiratory) and resource utilization (blood utilization, length of stay).

This project will allow us to confirm our retrospective findings that mini-bypass systems in conjunction with our modified protocol will benefit our smaller patients haematologically and lead to tremendous savings in blood utilization. The investigators will also establish if this protocol is safe, and if there are additional benefits in terms of inflammation, clinical outcomes and resource utilization. Our findings will also be applicable throughout East Asia, as patients in the region generally lag our Western counterparts in size.

Conditions

Acute Kidney Injury; Neurological Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mini CPB (ECCO, Sorin, Italy)

Utilization of the mini CPB circuit (Extra Corporeal Circuit Optimized; Phisio, Sorin Group, Italy)

Group Type: ACTIVE_COMPARATOR

Utilization of the mini CPB circuit

Intervention Type: DEVICE

Comparison of the mini CPB circuit to conventional circuit

Conventional

Use of conventional CPB circuit

Group Type: PLACEBO_COMPARATOR

Utilization of the conventional circuit

Intervention Type: DRUG

Comparison of the mini CPB circuit to conventional circuit

Interventions

Utilization of the mini CPB circuit

Comparison of the mini CPB circuit to conventional circuit

Intervention Type: DEVICE

Utilization of the conventional circuit

Comparison of the mini CPB circuit to conventional circuit

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• first time on pump CABG revascularization

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Medical Research Council (NMRC), Singapore

OTHER_GOV

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lian K Ti, MBBS, MMed

Role: PRINCIPAL_INVESTIGATOR

National University Health System, Singapore

Locations

National University Health System

Singapore, , Singapore

Countries

Singapore

References

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.

Reference Type: BACKGROUND

PMID: 18291186 (View on PubMed)

Other Identifiers

NHG DSRB 2008/00332

Identifier Type: -

Identifier Source: org_study_id