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NCT Number: NCT06358079

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Blood Transfusion Complication Cardiovascular Complication Cardiovascular Diseases Coronary Disease Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Myocardial Ischemia Transfusion Reaction Vascular Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University Cardiac Surgery Hospital

Damascus, Syria

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Re-infusion of unwashed shed blood

Procedure

Use of an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump coronary artery surgery

Primary outcomes

  1. blood transfusion requirements

    Time frame: up to 5 days post-operatively

    volume of blood (ml) transfused

  2. inflammatory response

    Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively

    changes in IL-6

  3. alveolar/arterial oxygen pressure gradients

    Time frame: pre-, 4 hours post-operatively, and post-extubation

    changes in alveolar/arterial oxygen pressure gradients peri-operatively

  4. cost-benefit

    Time frame: up to 5 days postoperatively

    cost of blood products, circuits and hospital stay

  5. Neuro-markers

    Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively

    Changes in S-100

  6. myocardial marker CK-MB

    Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively

    changes in CK-MB

  7. myocardial marker troponin-I

    Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively

    changes in troponin-I

  8. blood loss

    Time frame: up to 24 hours post-operatively

    volume (ml) of blood lost

  9. complement response

    Time frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively

    changes in C3a

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Isolated Cardiotomy Circuit for Re-infusion of Unwashed Shed Blood During Off-pump Coronary Artery Surgery

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 10, 2024
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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