Clinical trial NCT06358079: Re-infusion of Unwashed Shed Blood During Off-pump Surgery
Official title: Isolated Cardiotomy Circuit for Re-infusion of Unwashed Shed Blood During Off-pump Coronary Artery Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Blood Transfusion Complication
Cardiovascular Complication
Keywords: surgery
coronary artery bypass grafting
blood
off-pump
auto-transfusion
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: blood transfusion requirements
timeFrame: up to 5 days post-operatively
measure: inflammatory response
timeFrame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
measure: alveolar/arterial oxygen pressure gradients
timeFrame: pre-, 4 hours post-operatively, and post-extubation
measure: cost-benefit
timeFrame: up to 5 days postoperatively
measure: Neuro-markers
timeFrame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
measure: myocardial marker CK-MB
timeFrame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
measure: myocardial marker troponin-I
timeFrame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
measure: blood loss
timeFrame: up to 24 hours post-operatively
measure: complement response
timeFrame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University Cardiac Surgery Hospital
Study officials:
affiliation: Damascus University
name: Mohammad Bashar Izzat, FRCS(CTh)
role: STUDY_CHAIR
References:
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