Re-infusion of Unwashed Shed Blood During Off-pump Surgery

Damascus University

Status

Enrolling

Conditions

Blood Transfusion Complication

Coronary Artery Disease

Cardiovascular Complication

Treatments

Procedure: Re-infusion of unwashed shed blood

Study type

Interventional

Funder types

Other

Identifiers

NCT06358079

258

Details and patient eligibility

About

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.

Full 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

Enrollment

50 estimated patients

Sex

All

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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.