## Protocol Section
### Identification Module
**NCT ID:** NCT06358079

**Brief Title:** Re-infusion of Unwashed Shed Blood During Off-pump Surgery

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

#### Organization Study ID Info
**ID:** 258
#### Organization
**Class:** OTHER
**Full Name:** Damascus University
### Status Module
#### Completion Date
**Date:** 2026-03-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-10

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-06

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-03-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-27

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2024-04-10
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-27
**Study First Submit QC Date:** 2024-04-06
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Damascus University

#### Responsible Party

**Investigator Affiliation:** Damascus University

**Investigator Full Name:** Mohammad Bashar Izzat

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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

### Conditions Module

**Conditions:**

- Coronary Artery Disease

- Blood Transfusion Complication

- Cardiovascular Complication

**Keywords:**

- surgery

- coronary artery bypass grafting

- blood

- off-pump

- auto-transfusion

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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).

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Outcome assessor will be blinded to the group type when analyzing data

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Re-infusion of unwashed shed blood

**Intervention Names:**

- Procedure: Re-infusion of unwashed shed blood

**Label:** Group 1: Use of circuit

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** No re-infusion of unwashed shed blood

**Label:** Group 2: No circuit

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 1: Use of circuit

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

**Name:** Re-infusion of unwashed shed blood

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** volume of blood (ml) transfused

**Measure:** blood transfusion requirements

**Time Frame:** up to 5 days post-operatively

**Description:** changes in IL-6

**Measure:** inflammatory response

**Time Frame:** pre-operatively, immediately post-operatively, and 24 hours post-operatively

**Description:** changes in alveolar/arterial oxygen pressure gradients peri-operatively

**Measure:** alveolar/arterial oxygen pressure gradients

**Time Frame:** pre-, 4 hours post-operatively, and post-extubation

**Description:** cost of blood products, circuits and hospital stay

**Measure:** cost-benefit

**Time Frame:** up to 5 days postoperatively

**Description:** Changes in S-100

**Measure:** Neuro-markers

**Time Frame:** pre-operatively, immediately post-operatively, and 24 hours post-operatively

**Description:** changes in CK-MB

**Measure:** myocardial marker CK-MB

**Time Frame:** pre-operatively, immediately post-operatively, and 24 hours post-operatively

**Description:** changes in troponin-I

**Measure:** myocardial marker troponin-I

**Time Frame:** pre-operatively, immediately post-operatively, and 24 hours post-operatively

**Description:** volume (ml) of blood lost

**Measure:** blood loss

**Time Frame:** up to 24 hours post-operatively

**Description:** changes in C3a

**Measure:** complement response

**Time Frame:** pre-operatively, immediately post-operatively, and 24 hours post-operatively

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 75 Years

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mbizzat@damascusuniversity.edu.sy

**Name:** Albaraa Bara, MD

**Phone:** 0934206291

**Role:** CONTACT

**Contact 2:**

**Email:** nour.kara.tahan@gmail.com

**Name:** Nour Kara Tahhan, MD

**Phone:** 0933295582

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Damascus

**Contacts:**

***Contact 1:***

- **Email:** mbizzat@gmail.com

- **Name:** Mohammad Bashar Izzat, FRCS

- **Phone:** +963943240820

- **Role:** CONTACT

***Contact 2:***

- **Email:** mbizzat@damascusuniversity.edu.sy

- **Name:** Albaraa Bara, MD

- **Phone:** 0934206291

- **Role:** CONTACT

**Country:** Syrian Arab Republic

**Facility:** Damascus University Cardiac Surgery Hospital

**Status:** RECRUITING

#### Overall Officials

**Official 1:**

**Affiliation:** Damascus University

**Name:** Mohammad Bashar Izzat, FRCS(CTh)

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Access Criteria:** Open to all

**Description:** Data will be deposited in a Data Repository

**Info Types:**

- STUDY_PROTOCOL

- SAP

- ICF

- CSR

- ANALYTIC_CODE

**IPD Sharing:** YES

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

### References Module

#### References

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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

**Citation:** 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.

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**Citation:** 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.

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**Citation:** 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.

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**PMID:** 28475670

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000007154

- Term: Immune System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M30490

- Name: Transfusion Reaction

- Relevance: HIGH

- As Found: Blood Transfusion Complication

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

- ID: D000065227

- Term: Transfusion Reaction

### Misc Info Module

- Version Holder: 2024-05-24
