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临床试验/NCT05754294
NCT05754294撤回不适用

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

Anthea Hospital Bari1 个研究点 分布在 1 个国家开始时间: 2023年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Erythrocyte Sedimentation Rate (ESR)

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

结局指标

主要结局

Erythrocyte Sedimentation Rate (ESR)

时间窗: At the end of Cardiopulmonary Bypass

Inflammation

Erythrocytes Membrane Integrity

时间窗: At the end of Cardiopulmonary Bypass

Conservation of charge after polarization

Plasma Free Hemoglobin (pFHb)

时间窗: At the end of Cardiopulmonary Bypass

Hemolysis

次要结局

未报告次要终点

研究者

发起方
Anthea Hospital Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignazio Condello

Principal Investigator

Anthea Hospital Bari

研究点 (1)

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