Blood Transfusion Complication, Cardiovascular Complication, Coronary Artery Disease
Conditions
Keywords
surgery, coronary artery bypass grafting, blood, off-pump, auto-transfusion
Brief summary
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.
Detailed description
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
Interventions
PROCEDURERe-infusion of unwashed shed blood
Use of an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump coronary artery surgery
Sponsors
Damascus University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessor will be blinded to the group type when analyzing data
Intervention model description
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).
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* All patients undergoing isolated off-pump coronary artery bypass surgery between March 1st, 2024 and March 31st, 2026.
Exclusion criteria
* Missing data. * Patients outside the study period. * Patients under the age of 40 years or over the age of 75 years. * Patients with impaired left ventricular function (EF less the 40%). * Patients with history of renal failure, hepatic failure, CVA, or TIA. * Patients who have not stopped anticoagulants (except aspirin) for 4 days preoperatively. * Emergency operations.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| blood transfusion requirements | up to 5 days post-operatively | volume of blood (ml) transfused |
| inflammatory response | pre-operatively, immediately post-operatively, and 24 hours post-operatively | changes in IL-6 |
| alveolar/arterial oxygen pressure gradients | pre-, 4 hours post-operatively, and post-extubation | changes in alveolar/arterial oxygen pressure gradients peri-operatively |
| cost-benefit | up to 5 days postoperatively | cost of blood products, circuits and hospital stay |
| Neuro-markers | pre-operatively, immediately post-operatively, and 24 hours post-operatively | Changes in S-100 |
| myocardial marker CK-MB | pre-operatively, immediately post-operatively, and 24 hours post-operatively | changes in CK-MB |
| myocardial marker troponin-I | pre-operatively, immediately post-operatively, and 24 hours post-operatively | changes in troponin-I |
| blood loss | up to 24 hours post-operatively | volume (ml) of blood lost |
| complement response | pre-operatively, immediately post-operatively, and 24 hours post-operatively | changes in C3a |
Countries
Syria
Contacts
STUDY_CHAIRMohammad Bashar Izzat, FRCS(CTh)
Damascus University
Outcome results
None listed