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

Last updated: April 6, 2024
Sponsor: Damascus University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypercholesterolemia

Cardiovascular Disease

Atherosclerosis

Treatment

Re-infusion of unwashed shed blood

Clinical Study ID

NCT06358079
258
  • Ages 40-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All patients undergoing isolated off-pump coronary artery bypass surgery between March 1st, 2024 and March 31st, 2026.

Exclusion

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 dayspreoperatively.
  • Emergency operations.

Study Design

Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Re-infusion of unwashed shed blood
Phase:
Study Start date:
March 27, 2024
Estimated Completion Date:
March 30, 2026

Study 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

Connect with a study center

  • Damascus University Cardiac Surgery Hospital

    Damascus,
    Syrian Arab Republic

    Active - Recruiting

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