To assess the efficacy and side-effects of re-infusion of unwashed shed blood during off-pump coronary artery surgery using a novel cardiotomy circuit.
Introduction Blood transfusion is often required during cardiac surgical operations, and may be associated with known risks and complications. Off-pump coronary artery surgery has been shown to be associated with reduced need for blood transfusion, and cell-savers are widely used as an additional method for reducing blood transfusion demands. Auto-transfusion of unwashed suctioned blood intra-operatively is thought to increase the inflammatory response and infective complications, but data related to this approach are scares. Aims To assess the effects and benefits of using an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump surgery and compare it to the conventional no re-infusion technique. Assessments will focus on: * clinical outcome * transfusion requirements * inflammatory response * alveolar/arterial oxygen pressure gradients * cognitive status * cost-benefit Study design A prospective study involving patients undergoing off-pump coronary artery bypass surgery. Patients will be randomized to two groups; an isolated cardiotomy circuit for re-infusion of unwashed shed blood will be used in group (a) and the conventional no re-infusion technique will be used in group (b). Participants Patients undergoing off-pump coronary artery bypass surgery. Setting Damascus University Cardiac Surgery Hospital
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Use of an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump coronary artery surgery
Damascus University Cardiac Surgery Hospital
Damascus, Syria
RECRUITINGblood transfusion requirements
volume of blood (ml) transfused
Time frame: up to 5 days post-operatively
inflammatory response
changes in IL-6
Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
alveolar/arterial oxygen pressure gradients
changes in alveolar/arterial oxygen pressure gradients peri-operatively
Time frame: pre-, 4 hours post-operatively, and post-extubation
cost-benefit
cost of blood products, circuits and hospital stay
Time frame: up to 5 days postoperatively
Neuro-markers
Changes in S-100
Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
myocardial marker CK-MB
changes in CK-MB
Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
myocardial marker troponin-I
changes in troponin-I
Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
blood loss
volume (ml) of blood lost
Time frame: up to 24 hours post-operatively
complement response
changes in C3a
Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
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