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

NCT06358079 | Active Not Recruiting

• 1 other identifier: 258
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Blood Transfusion Complication; Cardiovascular Complication

Keywords

surgery; coronary artery bypass grafting; blood; off-pump; auto-transfusion

Outcome Measures

Primary Outcomes (9)

• blood transfusion requirements

  volume of blood (ml) transfused

  up to 5 days post-operatively

• inflammatory response

  changes in IL-6

  pre-operatively, immediately post-operatively, and 24 hours post-operatively

• alveolar/arterial oxygen pressure gradients

  changes in alveolar/arterial oxygen pressure gradients peri-operatively

  pre-, 4 hours post-operatively, and post-extubation

• cost-benefit

  cost of blood products, circuits and hospital stay

  up to 5 days postoperatively

• Neuro-markers

  Changes in S-100

  pre-operatively, immediately post-operatively, and 24 hours post-operatively

• myocardial marker CK-MB

  changes in CK-MB

  pre-operatively, immediately post-operatively, and 24 hours post-operatively

• myocardial marker troponin-I

  changes in troponin-I

  pre-operatively, immediately post-operatively, and 24 hours post-operatively

• blood loss

  volume (ml) of blood lost

  up to 24 hours post-operatively

• complement response

  changes in C3a

  pre-operatively, immediately post-operatively, and 24 hours post-operatively

Study Arms (2)

Group 1: Use of circuit

EXPERIMENTAL

Re-infusion of unwashed shed blood

Procedure: Re-infusion of unwashed shed blood

Group 2: No circuit

NO INTERVENTION

No re-infusion of unwashed shed blood

Interventions

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

Group 1: Use of circuit

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University Cardiac Surgery Hospital

Damascus, Syria

Location

Related Publications (21)

• 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.

  PMID: 21627923 BACKGROUND

• 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.

  PMID: 24955005 BACKGROUND

• 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.

  PMID: 16733169 BACKGROUND

• 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.

  PMID: 23404689 BACKGROUND

• 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.

  PMID: 30968273 BACKGROUND

• 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.

  PMID: 35782418 BACKGROUND

• 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.

  PMID: 22206712 BACKGROUND

• 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.

  PMID: 17257991 BACKGROUND

• 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.

  PMID: 22730871 BACKGROUND

• 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.

  PMID: 27668331 BACKGROUND

• 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.

  PMID: 26705299 BACKGROUND

• 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.

  PMID: 28084083 BACKGROUND

• 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.

  PMID: 15173716 BACKGROUND

• 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.

  PMID: 25207243 BACKGROUND

• 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.

  PMID: 11153289 BACKGROUND

• 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.

  PMID: 21084005 BACKGROUND

• 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.

  PMID: 15999036 BACKGROUND

• 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.

  PMID: 32620259 BACKGROUND

• 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.

  PMID: 10421114 BACKGROUND

• 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.

  PMID: 31791879 BACKGROUND

• 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.

  PMID: 28475670 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Transfusion Reaction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases

Study Officials

• Mohammad Bashar Izzat, FRCS(CTh)

  Damascus University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessor will be blinded to the group type when analyzing data
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 10, 2024
• Study Start: March 27, 2024
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon completion of the study and will be there permanently
• Access Criteria: Open to all

Locations

SY (1)