Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery. (Polaris)

Electric Polarization of Red Blood Cells "Polaris": A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Conventional and Minimally Invasive Cardiac Surgery Procedures and The Related Perfusion Techniques

An immediate perioperative parameter that assess the integrity of the Erythrocytes Membrane and therefore their structural quality isn't available in clinical practice and medical diagnostics except through indirect clinical biochemical tests or through the scanning electron microscope. The red blood cell (RBC) membrane contains proteins and glycoproteins embedded in a fluid lipid bilayer that confers viscoelastic behavior. Sialylated glycoproteins of the RBC membrane are responsible for a negatively charged surface which creates a repulsive electric zeta potential (ζ) between cells. These charges help prevent the interaction between RBCs and the other cells and especially between each other. The zeta potential is a physical property which is exhibited by all particles in suspension. The development of a net charge on any particle affects the distribution of ions in the surrounding interfacial region resulting in an increased concentration of counter ions of opposite charge to that of the particle, close to the surface. In this context we present a new parameter that studies the interactions of the Erythrocytes membrane treated with positive ions and their maintenance of the charge. We compared the measured polarization values with the Erythrocyte Sedimentation Rate (ESR), expression of speed with which RBCs tend to settle inside a particular graduated capillary called Westergren's tube and Plasma Free Hemoglobin (pFHb).

Study Overview

• Status: Not yet recruiting
• Conditions: Inflammatory Response; Hemolysis; Cardiovascular Disorder; Red Blood Cell Disorder; Erythrocyte Destruction
• Intervention / Treatment: Diagnostic test: Polarization of red blood cells

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: Ignazio Condello, PhD; Phone Number: +393204608352; Email: ignicondello@hotmail.it

Study Locations

• Italy
  • Bari, Italy, 70124
    • Anthea Hospital
    • Contact: Giuseppe Nasso, PhD
    • Principal Investigator: Giuseppe Nasso, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Have been collected a perspective cohort of Eighty elective Cardiac Surgery procedures with Cardiopulmonary bypass (CPB) in a single tertiary institution Anthea Hospital Gvm Care & Research, Bari, Italy. Forty patients were treated for Coronary Artery Bypass Grafting (CABG) of which (n=20), were allocated for Conventional Cardiopulmonary Bypass (cCPB) and (n=20), were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. Forty patients were treated for Minimally Invasive Mitral Valve Repair (MIMVR); (n=20), reported a CPB time (< 60 min.) and (n=20), a CPB time (>100 min.).

Description

Inclusion Criteria:

• Elective, primary cardiac surgery
• Minimally invasive cardiac surgery
• Mitral Valve Surgery (MVS)
• Conventional cardiac surgery (CCS)
• Coronary Arterial Bypass Grafting (CABG).

Exclusion Criteria:

• Abnormal plasma lactate levels (>2 mmol/L)
• Renal
• Liver failure,
• Obesity,
• Uncompensated diabetes,
• Autoimmune disease, active infection
• Immunosuppressant therapy
• Coagulation disorder
• Surgery with circulatory arrest
• Preoperative hematocrit (Hct) <27%

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB); (n=20) patients, were allocated for Conventional Cardiopulmonary Bypass (cCPB)	Diagnostic test: Polarization of red blood cells; Pre and perioperative data blood sample were collected for each patient 5 minutes (min) before the CPB start and 5 minutes before the end of the CPB for Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) and Plasma Free Hemoglobin (pFHb). At the end of CPB the residual blood from the extracorporeal circulation was treated with cell-saver and the treated and concentrated red blood cells were collected in a transfusion bag. Two milliliters (ml) was taken from the bag, one ml was subjected to a blood gas test for the evaluation of the Hemoglobin (Hb) content and one ml was subjected inside a cuvette to the release of positive ions (polarization) with a charge of 50 Millivolt (mV) for a time of 5 seconds through charge circuit, after the trend of the conserved charge was measured through a multimeter, instrument that can measure multiple electrical properties.
Coronary arteries bypass grafting with Minimally invasive extracorporeal circulation (MiECC); (n=20) patients, were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III.	Diagnostic test: Polarization of red blood cells; Pre and perioperative data blood sample were collected for each patient 5 minutes (min) before the CPB start and 5 minutes before the end of the CPB for Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) and Plasma Free Hemoglobin (pFHb). At the end of CPB the residual blood from the extracorporeal circulation was treated with cell-saver and the treated and concentrated red blood cells were collected in a transfusion bag. Two milliliters (ml) was taken from the bag, one ml was subjected to a blood gas test for the evaluation of the Hemoglobin (Hb) content and one ml was subjected inside a cuvette to the release of positive ions (polarization) with a charge of 50 Millivolt (mV) for a time of 5 seconds through charge circuit, after the trend of the conserved charge was measured through a multimeter, instrument that can measure multiple electrical properties.
Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.); (n=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.)	Diagnostic test: Polarization of red blood cells; Pre and perioperative data blood sample were collected for each patient 5 minutes (min) before the CPB start and 5 minutes before the end of the CPB for Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) and Plasma Free Hemoglobin (pFHb). At the end of CPB the residual blood from the extracorporeal circulation was treated with cell-saver and the treated and concentrated red blood cells were collected in a transfusion bag. Two milliliters (ml) was taken from the bag, one ml was subjected to a blood gas test for the evaluation of the Hemoglobin (Hb) content and one ml was subjected inside a cuvette to the release of positive ions (polarization) with a charge of 50 Millivolt (mV) for a time of 5 seconds through charge circuit, after the trend of the conserved charge was measured through a multimeter, instrument that can measure multiple electrical properties.
Minimally invasive mitral valve repair (MIMVR) with CPB time (>100 min.); n=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (> 100 min.)	Diagnostic test: Polarization of red blood cells; Pre and perioperative data blood sample were collected for each patient 5 minutes (min) before the CPB start and 5 minutes before the end of the CPB for Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR) and Plasma Free Hemoglobin (pFHb). At the end of CPB the residual blood from the extracorporeal circulation was treated with cell-saver and the treated and concentrated red blood cells were collected in a transfusion bag. Two milliliters (ml) was taken from the bag, one ml was subjected to a blood gas test for the evaluation of the Hemoglobin (Hb) content and one ml was subjected inside a cuvette to the release of positive ions (polarization) with a charge of 50 Millivolt (mV) for a time of 5 seconds through charge circuit, after the trend of the conserved charge was measured through a multimeter, instrument that can measure multiple electrical properties.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Erythrocytes Membrane Integrity	Conservation of charge after polarization	At the end of Cardiopulmonary Bypass
Erythrocyte Sedimentation Rate (ESR)	Inflammation	At the end of Cardiopulmonary Bypass
Plasma Free Hemoglobin (pFHb)	Hemolysis	At the end of Cardiopulmonary Bypass

Collaborators and Investigators

• Sponsor: Anthea Hospital Bari

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: February 22, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 21, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Hemolysis
• Other Study ID Numbers: AntheaH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No