ClinicalTrials.gg
CompletedNCT06358079Updated Sep 1, 2026

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

An interventional study of Re-infusion of unwashed shed blood in Coronary Artery Disease, Blood Transfusion Complication and Cardiovascular Complication, sponsored by Damascus University. Completed at 1 site in Syria. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Damascus University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

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.

Read the 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

02

Conditions studied

  • Coronary Artery Disease
  • Blood Transfusion Complication
  • Cardiovascular Complication

Keywords

  • surgery
  • coronary artery bypass grafting
  • blood
  • off-pump
  • auto-transfusion
03

In context

Coronary Artery Disease

4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.

This study's enrollment of 50 is below the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Damascus University is the lead sponsor of 212 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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 .
  • Patients who have not stopped anticoagulants (except aspirin) for 4 days preoperatively.
  • Emergency operations.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Group 1: Use of circuit

    Re-infusion of unwashed shed blood

    Procedure: Re-infusion of unwashed shed blood

  • No intervention
    Group 2: No circuit

    No re-infusion of unwashed shed blood

Interventions

  • ProcedureRe-infusion of unwashed shed blood

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

06

What researchers measure

Primary outcomes

  1. blood transfusion requirements

    volume of blood (ml) transfused

    Time frame: up to 5 days post-operatively

  2. inflammatory response

    changes in IL-6

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

  3. alveolar/arterial oxygen pressure gradients

    changes in alveolar/arterial oxygen pressure gradients peri-operatively

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

  4. cost-benefit

    cost of blood products, circuits and hospital stay

    Time frame: up to 5 days postoperatively

  5. Neuro-markers

    Changes in S-100

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

  6. myocardial marker CK-MB

    changes in CK-MB

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

  7. myocardial marker troponin-I

    changes in troponin-I

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

  8. blood loss

    volume (ml) of blood lost

    Time frame: up to 24 hours post-operatively

  9. complement response

    changes in C3a

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

07

Study locations

1 site
  • Damascus University Cardiac Surgery Hospital
    Damascus, Syria
08

References and documents

Publications

  • Liumbruno GM, Waters JH. Unwashed shed blood: should we transfuse it? Blood Transfus. 2011 Jul;9(3):241-5. doi: 10.2450/2011.0109-10. Epub 2011 Apr 20. No abstract available. PubMed 21627923 ↗
  • Konig G, Waters JH. Washing and filtering of cell-salvaged blood - does it make autotransfusion safer? Transfus Altern Transfus Med. 2012 Dec 1;12(3-4):78-87. doi: 10.1111/j.1778-428X.2012.01155.x. No abstract available. PubMed 24955005 ↗
  • Westerberg M, Gabel J, Bengtsson A, Sellgren J, Eidem O, Jeppsson A. Hemodynamic effects of cardiotomy suction blood. J Thorac Cardiovasc Surg. 2006 Jun;131(6):1352-7. doi: 10.1016/j.jtcvs.2005.12.067. PubMed 16733169 ↗
  • Gabel J, Westerberg M, Bengtsson A, Jeppsson A. Cell salvage of cardiotomy suction blood improves the balance between pro- and anti-inflammatory cytokines after cardiac surgery. Eur J Cardiothorac Surg. 2013 Sep;44(3):506-11. doi: 10.1093/ejcts/ezt019. Epub 2013 Feb 12. PubMed 23404689 ↗
  • Yasukawa T, Manabe S, Hiraoka D, Hirayama D, Kinoshita R, Komori M, Hosokawa M, Hirooka K. Safety and efficacy of a simple cardiotomy suction system as a blood salvage procedure during off-pump coronary artery bypass surgery. J Artif Organs. 2019 Sep;22(3):194-199. doi: 10.1007/s10047-019-01103-9. Epub 2019 Apr 9. PubMed 30968273 ↗
  • Vu T, Smith JA. An Update on Postoperative Cognitive Dysfunction Following Cardiac Surgery. Front Psychiatry. 2022 Jun 15;13:884907. doi: 10.3389/fpsyt.2022.884907. eCollection 2022. PubMed 35782418 ↗
  • Dabrowski W, Rzecki Z, Czajkowski M, Pilat J, Wacinski P, Kotlinska E, Sztanke M, Sztanke K, Stazka K, Pasternak K. Volatile anesthetics reduce biochemical markers of brain injury and brain magnesium disorders in patients undergoing coronary artery bypass graft surgery. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):395-402. doi: 10.1053/j.jvca.2011.10.014. Epub 2011 Dec 28. PubMed 22206712 ↗
  • Allen SJ, McBride WT, McMurray TJ, Phillips AS, Penugonda SP, Campalani G, Young IS, Armstrong MA. Cell salvage alters the systemic inflammatory response after off-pump coronary artery bypass grafting surgery. Ann Thorac Surg. 2007 Feb;83(2):578-85. doi: 10.1016/j.athoracsur.2006.09.041. PubMed 17257991 ↗
  • Baker RA, Merry AF. Cell salvage is beneficial for all cardiac surgical patients: arguments for and against. J Extra Corpor Technol. 2012 Mar;44(1):P38-41. PubMed 22730871 ↗
  • Cote CL, Yip AM, MacLeod JB, O'Reilly B, Murray J, Ouzounian M, Brown CD, Forgie R, Pelletier MP, Hassan A. Efficacy of intraoperative cell salvage in decreasing perioperative blood transfusion rates in first-time cardiac surgery patients: a retrospective study. Can J Surg. 2016 Sep;59(5):330-6. doi: 10.1503/cjs.002216. PubMed 27668331 ↗
  • Engels GE, van Klarenbosch J, Gu YJ, van Oeveren W, de Vries AJ. Intraoperative cell salvage during cardiac surgery is associated with reduced postoperative lung injury. Interact Cardiovasc Thorac Surg. 2016 Mar;22(3):298-304. doi: 10.1093/icvts/ivv355. Epub 2015 Dec 23. PubMed 26705299 ↗
  • Izzat MB, Almohammad F, Raslan AF. Off-pump grafting does not reduce postoperative pulmonary dysfunction. Asian Cardiovasc Thorac Ann. 2017 Feb;25(2):113-117. doi: 10.1177/0218492316689350. Epub 2017 Jan 13. PubMed 28084083 ↗
  • Wan IY, Arifi AA, Wan S, Yip JH, Sihoe AD, Thung KH, Wong EM, Yim AP. Beating heart revascularization with or without cardiopulmonary bypass: evaluation of inflammatory response in a prospective randomized study. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1624-31. doi: 10.1016/j.jtcvs.2003.10.043. PubMed 15173716 ↗
  • Kim KI, Lee WY, Ko HH, Kim HS, Jeong JH. Hemoglobin Level to Facilitate Off-Pump Coronary Artery Bypass without Transfusion. Korean J Thorac Cardiovasc Surg. 2014 Aug;47(4):350-7. doi: 10.5090/kjtcs.2014.47.4.350. Epub 2014 Aug 5. PubMed 25207243 ↗
  • Kitano T, Hattori S, Miyakawa H, Yoshitake S, Iwasaka H, Noguchi T. Unwashed shed blood infusion causes deterioration in right ventricular function after coronary artery surgery. Anaesth Intensive Care. 2000 Dec;28(6):642-5. doi: 10.1177/0310057X0002800605. PubMed 11153289 ↗
  • Munoz M, Slappendel R, Thomas D. Laboratory characteristics and clinical utility of post-operative cell salvage: washed or unwashed blood transfusion? Blood Transfus. 2011 Jul;9(3):248-61. doi: 10.2450/2010.0063-10. Epub 2010 Sep 14. No abstract available. PubMed 21084005 ↗
  • Murphy GJ, Rogers CS, Lansdowne WB, Channon I, Alwair H, Cohen A, Caputo M, Angelini GD. Safety, efficacy, and cost of intraoperative cell salvage and autotransfusion after off-pump coronary artery bypass surgery: a randomized trial. J Thorac Cardiovasc Surg. 2005 Jul;130(1):20-8. doi: 10.1016/j.jtcvs.2004.12.006. PubMed 15999036 ↗
  • Roman MA, Abbasciano RG, Pathak S, Oo S, Yusoff S, Wozniak M, Qureshi S, Lai FY, Kumar T, Richards T, Yao G, Estcourt L, Murphy GJ. Patient blood management interventions do not lead to important clinical benefits or cost-effectiveness for major surgery: a network meta-analysis. Br J Anaesth. 2021 Jan;126(1):149-156. doi: 10.1016/j.bja.2020.04.087. Epub 2020 Jun 30. PubMed 32620259 ↗
  • Wan S, Izzat MB, Lee TW, Wan IY, Tang NL, Yim AP. Avoiding cardiopulmonary bypass in multivessel CABG reduces cytokine response and myocardial injury. Ann Thorac Surg. 1999 Jul;68(1):52-6; discussion 56-7. doi: 10.1016/s0003-4975(99)00315-x. PubMed 10421114 ↗
  • Vieira SD, da Cunha Vieira Perini F, de Sousa LCB, Buffolo E, Chaccur P, Arrais M, Jatene FB. Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin. Hematol Transfus Cell Ther. 2021 Jan-Mar;43(1):1-8. doi: 10.1016/j.htct.2019.08.005. Epub 2019 Nov 7. PubMed 31791879 ↗
  • Wozniak MJ, Sullo N, Qureshi S, Dott W, Cardigan R, Wiltshire M, Morris T, Nath M, Bittar N, Bhudia SK, Kumar T, Goodall AH, Murphy GJ. Randomized trial of red cell washing for the prevention of transfusion-associated organ injury in cardiac surgery. Br J Anaesth. 2017 May 1;118(5):689-698. doi: 10.1093/bja/aex083. PubMed 28475670 ↗

Individual participant data

Plan to share: Yes — Data will be deposited in a Data Repository

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: Upon completion of the study and will be there permanently

Access criteria: Open to all

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2024 to primary completion in Mar 2026, 24 months.

Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's 24 months is below that.

Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 27, 2024
First posted
Apr 10, 2024
StartActual
Mar 27, 2024
Primary completionActual
Mar 30, 2026
CompletionActual
Mar 30, 2026
Last update
Sep 1, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06358079
Responsible party
Sponsor
First posted
Apr 10, 2024
Start date
Mar 27, 2024
Primary completion
Mar 30, 2026
Completion
Mar 30, 2026
Last update
Sep 1, 2026

Study contacts

Mohammad Bashar Izzat, FRCS(CTh)
study chair · Damascus University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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