Isolated Cardiotomy Circuit for Re-infusion of Unwashed Shed Blood During Off-pump Coronary Artery Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Damascus University
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- blood transfusion requirements
Study Overview
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
- Study Type
- Interventional
- 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
Eligibility Criteria
- Ages
- 40 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Group 2: No circuit
No re-infusion of unwashed shed blood
Group 1: Use of circuit
Re-infusion of unwashed shed blood
Intervention: Re-infusion of unwashed shed blood (Procedure)
Outcomes
Primary Outcomes
blood transfusion requirements
Time Frame: up to 5 days post-operatively
volume of blood (ml) transfused
inflammatory response
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in IL-6
alveolar/arterial oxygen pressure gradients
Time Frame: pre-, 4 hours post-operatively, and post-extubation
changes in alveolar/arterial oxygen pressure gradients peri-operatively
cost-benefit
Time Frame: up to 5 days postoperatively
cost of blood products, circuits and hospital stay
Neuro-markers
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
Changes in S-100
myocardial marker CK-MB
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in CK-MB
complement response
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in C3a
blood loss
Time Frame: up to 24 hours post-operatively
volume (ml) of blood lost
myocardial marker troponin-I
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in troponin-I
Secondary Outcomes
No secondary outcomes reported