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Completed

NCT Number: NCT03657225

Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients

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.

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Key information

Age range

21 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National University Health System

Singapore, 119074

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Utilization of the mini CPB circuit

Device

Comparison of the mini CPB circuit to conventional circuit

Utilization of the conventional circuit

Drug

Comparison of the mini CPB circuit to conventional circuit

Primary outcomes

  1. Acute kidney injury

    Time frame: 48 hours after surgery

    Meeting AKIN 1 criteria

Secondary outcomes

  1. Neurocognitive decline

    Time frame: 3 months post surgery

    Use of Neurocognitive test / questionnaire: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  2. Inflammation

    Time frame: 72 hours post surgery

    Markers for inflammation will be measured preoperatively, and daily till the 3rd postoperative day, including TNF-alpha, IL-6 and C-Reactive Protein.

Other outcomes

  1. Atrial fibrillation

    Time frame: 7 days post surgery

Sponsors and collaborators

Lead sponsor

National University Hospital, Singapore

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore

Registry information

Official study title

Comparison Of Mini-Bypass To Conventional Cardiopulmonary Bypass In Asian Patients Undergoing Coronary Artery Bypass Grafting Surgery

Acronym: MiniCPB

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Sep 5, 2018
Registry last updated
Sep 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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