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

NCT ID: NCT05754294

Last Updated: 2024-07-30

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-01

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB)

(n=20) patients, were allocated for Conventional Cardiopulmonary Bypass (cCPB)

Polarization of red blood cells

Intervention Type: 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)

(n=20) patients, were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III.

Polarization of red blood cells

Intervention Type: 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.

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.)

Polarization of red blood cells

Intervention Type: 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.

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.)

Polarization of red blood cells

Intervention Type: 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.

Interventions

Polarization of red blood cells

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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%

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anthea Hospital Bari

OTHER

Sponsor Role: lead

Responsible Party

Ignazio Condello

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Anthea Hospital

Bari, , Italy

Countries

Italy

Other Identifiers

AntheaH

Identifier Type: -

Identifier Source: org_study_id