Mini Versus Conventional Cardiopulmonary Bypass In CABG in Asian Patients
Condition: Acute Kidney Injury; Neurological Injury
MeSH terms: Trauma, Nervous System; Acute Kidney Injury; Wounds and Injuries
Study type: Interventional

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.
    

Intervention name(s): Utilization of the mini CPB circuit; Utilization of the conventional circuit
Intervention type(s): Device; Drug
Intervention description(s): Comparison of the mini CPB circuit to conventional circuit; Comparison of the mini CPB circuit to conventional circuit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: miniaturized; cardiopulmonary bypass