Inflammatory ResponsePolarisNCT05754294
Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
An observational study of Inflammatory Response and Erythrocyte Destruction, run by Anthea Hospital Bari at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Inflammatory Response, Erythrocyte Destruction, Red Blood Cell Disorder
- What is being tested?
- Polarization of red blood cells
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Have been collected a perspective cohort of Eighty elective Cardiac Surgery procedures with Cardiopulmonary bypass (CPB) in a single tertiary institution Anthea Hospital Gvm Care \& Research, Bari, Italy. Forty patients were treated for Coronary Artery Bypass Grafting (CABG) of which (n=20), were allocated for Conventional Cardiopulmonary Bypass (cCPB) and (n=20), were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. Forty patients were treated for Minimally Invasive Mitral Valve Repair (MIMVR); (n=20), reported a CPB time (< 60 min.) and (n=20), a CPB time (>100 min.).
Who may be able to join
- Elective, primary cardiac surgery
- Minimally invasive cardiac surgery
- Mitral Valve Surgery (MVS)
- Conventional cardiac surgery (CCS)
- Coronary Arterial Bypass Grafting (CABG).
Who cannot join
- Abnormal plasma lactate levels (>2 mmol/L)
- Renal
- Liver failure,
- Obesity,
- Uncompensated diabetes,
- Autoimmune disease, active infection
Show all 10Show fewer
- Immunosuppressant therapy
- Coagulation disorder
- Surgery with circulatory arrest
- Preoperative hematocrit (Hct) <27%
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Polarization of red blood cells
- Medical subject headings
- Hemolysis, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarization of red blood cellsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB) | (n=20) patients, were allocated for Conventional Cardiopulmonary Bypass (cCPB) Receives: Diagnostic Test: Polarization of red blood cells | |
| Coronary arteries bypass grafting with Minimally invasive extracorporeal circulation (MiECC) | (n=20) patients, were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. Receives: Diagnostic Test: Polarization of red blood cells | |
| 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.) Receives: Diagnostic Test: Polarization of red blood cells | |
| 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.) Receives: Diagnostic Test: Polarization of red blood cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocytes Membrane Integrity
Conservation of charge after polarization
Measured: At the end of Cardiopulmonary Bypass
Erythrocyte Sedimentation Rate (ESR)
Inflammation
Measured: At the end of Cardiopulmonary Bypass
Plasma Free Hemoglobin (pFHb)
Hemolysis
Measured: At the end of Cardiopulmonary Bypass
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Why it stopped: absence of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthea Hospital Bari
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignazio Condello, Anthea Hospital Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754294
- Sponsor's protocol ID
- AntheaH
- Acronym
- Polaris
- Status last verified
- Jul 2024
- First submitted
- 22 Feb 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05754294
- Acronym / sponsor ID
- Polaris / AntheaH
- Conditions
- Inflammatory Response, Erythrocyte Destruction, Red Blood Cell Disorder, Hemolysis, Cardiovascular Disorder
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: absence of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Anthea Hospital BariUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB) | – | Diagnostic Test: Polarization of red blood cells(n=20) patients, were allocated for Conventional Cardiopulmonary Bypass (cCPB) |
| Coronary arteries bypass grafting with Minimally invasive extracorporeal circulation (MiECC) | – | Diagnostic Test: Polarization of red blood cells(n=20) patients, were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. |
| Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.) | – | Diagnostic Test: Polarization of red blood cells(n=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.) |
| Minimally invasive mitral valve repair (MIMVR) with CPB time (>100 min.) | – | Diagnostic Test: Polarization of red blood cellsn=20) patients, were allocated for Minimally invasive mitral valve repair (MIMVR) with CPB time (> 100 min.) |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Have been collected a perspective cohort of Eighty elective Cardiac Surgery procedures with Cardiopulmonary bypass (CPB) in a single tertiary institution Anthea Hospital Gvm Care \& Research, Bari, Italy. Forty patients were treated for Coronary Artery Bypass Grafting (CABG) of which (n=20), were allocated for Conventional Cardiopulmonary Bypass (cCPB) and (n=20), were allocated for Minimal invasive Extracorporeal Circulation (MiECC) type III. Forty patients were treated for Minimally Invasive Mitral Valve Repair (MIMVR); (n=20), reported a CPB time (< 60 min.) and (n=20), a CPB time (>100 min.).
Key inclusion criteria (5 listed)
- Elective, primary cardiac surgery
- Minimally invasive cardiac surgery
- Mitral Valve Surgery (MVS)
- Conventional cardiac surgery (CCS)
- Coronary Arterial Bypass Grafting (CABG).
Key exclusion criteria (10 listed)
- Abnormal plasma lactate levels (>2 mmol/L)
- Renal
- Liver failure,
- Obesity,
- Uncompensated diabetes,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polarization 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. | Diagnostic test | Coronary arteries bypass grafting with Minimally invasive extracorporeal circulation (MiECC), Coronary arteries bypass grafting with conventional cardiopulmonary bypass (cCPB), Minimally invasive mitral valve repair (MIMVR) with CPB time (< 60 min.), Minimally invasive mitral valve repair (MIMVR) with CPB time (>100 min.) |
Primary outcome
Erythrocytes Membrane Integrity
Time frame: At the end of Cardiopulmonary Bypass
Conservation of charge after polarization
Erythrocyte Sedimentation Rate (ESR)
Time frame: At the end of Cardiopulmonary Bypass
Inflammation
Plasma Free Hemoglobin (pFHb)
Time frame: At the end of Cardiopulmonary Bypass
Hemolysis
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response and Erythrocyte Destruction, run by Anthea Hospital Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocytes Membrane Integrity (time frame: At the end of Cardiopulmonary Bypass). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.