Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-25 @ 11:46 PM
Study NCT ID:
NCT05754294
Status:
WITHDRAWN
Last Update Posted:
2024-07-30
First Post:
2023-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Sponsor:
Anthea Hospital Bari
Organization:
Study Overview
Official Title:
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WITHDRAWN
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
absence of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Polaris
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 (ΞΆ) 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: