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

April 6, 2024 updated by: Mohammad Bashar Izzat, Damascus University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1: Use of circuit
Re-infusion of unwashed shed blood
Procedure: Re-infusion of unwashed shed blood
Use of an isolated cardiotomy circuit for re-infusion of unwashed shed blood during off-pump coronary artery surgery
No Intervention: Group 2: No circuit
No re-infusion of unwashed shed blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood transfusion requirements
Time Frame: up to 5 days post-operatively
volume of blood (ml) transfused
up to 5 days post-operatively
inflammatory response
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in IL-6
pre-operatively, immediately post-operatively, and 24 hours post-operatively
alveolar/arterial oxygen pressure gradients
Time Frame: pre-, 4 hours post-operatively, and post-extubation
changes in alveolar/arterial oxygen pressure gradients peri-operatively
pre-, 4 hours post-operatively, and post-extubation
cost-benefit
Time Frame: up to 5 days postoperatively
cost of blood products, circuits and hospital stay
up to 5 days postoperatively
Neuro-markers
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
Changes in S-100
pre-operatively, immediately post-operatively, and 24 hours post-operatively
myocardial marker CK-MB
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in CK-MB
pre-operatively, immediately post-operatively, and 24 hours post-operatively
myocardial marker troponin-I
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in troponin-I
pre-operatively, immediately post-operatively, and 24 hours post-operatively
blood loss
Time Frame: up to 24 hours post-operatively
volume (ml) of blood lost
up to 24 hours post-operatively
complement response
Time Frame: pre-operatively, immediately post-operatively, and 24 hours post-operatively
changes in C3a
pre-operatively, immediately post-operatively, and 24 hours post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Investigators

  • Study Chair: Mohammad Bashar Izzat, FRCS(CTh), Damascus university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

March 30, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 6, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be deposited in a Data Repository

IPD Sharing Time Frame

Upon completion of the study and will be there permanently

IPD Sharing Access Criteria

Open to all

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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