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

NCT05754294 | Withdrawn DMC

• 1 other identifier: AntheaH
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Inflammatory Response; Erythrocyte Destruction; Red Blood Cell Disorder; Hemolysis; Cardiovascular Disorder

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

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

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

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

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

Interventions

Polarization of red blood cells DIAGNOSTIC_TEST

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); Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB); Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.); Minimally invasive mitral valve repair (MIMVR) with CPB time (>100 min.)

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.).

You may qualify if:

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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Anthea Hospital Bari: lead

Study Sites (1)

Anthea Hospital

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Hemolysis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 3, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IT (1)