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

A

Anthea Hospital Bari

Status

Withdrawn

Conditions

Hemolysis
Red Blood Cell Disorder
Inflammatory Response
Cardiovascular Disorder
Erythrocyte Destruction

Treatments

Diagnostic Test: Polarization of red blood cells

Study type

Observational

Funder types

Other

Identifiers

NCT05754294
AntheaH

Details and patient eligibility

About

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).

Sex

All

Volunteers

No Healthy Volunteers

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%

Trial design

0 participants in 4 patient groups

Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB)
Description:
(n=20) patients, were allocated for Conventional Cardiopulmonary Bypass (cCPB)
Treatment:
Diagnostic Test: Polarization of red blood cells
Coronary arteries bypass grafting with Minimally invasive extracorporeal circulation (MiECC)
Description:
(n=20) patients, were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III.
Treatment:
Diagnostic Test: Polarization of red blood cells
Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.)
Description:
(n=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (\< 60 min.)
Treatment:
Diagnostic Test: Polarization of red blood cells
Minimally invasive mitral valve repair (MIMVR) with CPB time (>100 min.)
Description:
n=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (\> 100 min.)
Treatment:
Diagnostic Test: Polarization of red blood cells

Trial contacts and locations

1

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Central trial contact

Ignazio Condello, PhD

Data sourced from clinicaltrials.gov

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