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Trials / Withdrawn

WithdrawnNCT05754294

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

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

Status
Withdrawn
Phase
Study type
Observational
Enrollment
0 (actual)
Sponsor
Anthea Hospital Bari · Academic / Other
Sex
All
Age
Healthy volunteers

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTPolarization of red blood cellsPre 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.

Timeline

Start date
2023-09-01
Primary completion
2023-10-01
Completion
2023-12-01
First posted
2023-03-03
Last updated
2024-07-30

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT05754294. Inclusion in this directory is not an endorsement.