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Hemolysis clinical trials

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NCT ID: NCT05757570 Recruiting - Clinical trials for Immune Thrombocytopenia

An Open-label Study of Povetacicept in Subjects With Autoimmune Cytopenias

RUBY-4
Start date: July 3, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate povetacicept in adults with autoimmune cytopenias of immune thrombocytopenia, autoimmune hemolytic anemia, and cold agglutinin disease to determine if povetacicept is safe and potentially beneficial in treating these diseases. During the study treatment period participants will receive povetacicept approximately every 4 weeks for 6 months, with the possibility of participating in a 6-month study treatment extension period.

NCT ID: NCT05754294 Not yet recruiting - Clinical trials for Inflammatory Response

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

Polaris
Start date: September 1, 2023
Phase:
Study type: Observational

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).

NCT ID: NCT05726916 Recruiting - Clinical trials for Hypertensive Emergency-associated Hemolytic Uremic Syndrome

Eculizumab in Hypertensive Emergency-associated Hemolytic Uremic Syndrome

HYPERSHU
Start date: November 9, 2023
Phase: Phase 3
Study type: Interventional

Hemolytic and uremic syndrome (HUS) is a clinic-biological syndrome related to thrombotic microangiopathy affecting predominantly the kidney. Atypical HUS (aHUS) has been historically defined as HUS occurring in the absence of infectious event. The role of complement dysregulation in aHUS pathophysiology has been largely demonstrated, since C genetic rare variants are present in 60-70% aHUS patients. In line with the frequency of C dysregulation in aHUS, Eculizumab, an anti-C5 monoclonal antibody, has dramatically improved aHUS patients prognosis. Numerous conditions have been associated with aHUS, including hypertensive emergency (HE), a syndrome of acute blood pressure flare associated with end-organ damage. In cases of HE-aHUS, whether primary aHUS is complicated by secondary HE, or primary HE leads to secondary aHUS is still debated. The investigators recently demonstrated that C genetic variants frequency was similar in patients with HE-aHUS and patients with aHUS without HE, suggesting a major role for C dysregulation in HE-aHUS. Consequently, the investigators propose to evaluate, in HE-aHUS patients, the benefit of a strategy with early Eculizumab therapy (used within its marketing authorization and its conditions of refunding by the health insurance in usual care), compared to standard of care including tight blood pressure control. The hypothesis suggests that C dysregulation may impact renal prognosis of HE-aHUS patients. The investigator's aim to demonstrate that early Eculizumab therapy improves prognosis of HE-aHUS patients. Method The HYPERSHU study is a randomized, controlled, open-labelled study including HE-aHUS patients with severe AKI and no evidence of other conditions associated with HUS (infections, autoimmunity, drugs, pregnancy). The investigators plan to include 62 patients. Patients will be randomized in 2 arms: - Early Eculizumab therapy (for 3 months) added to standard of care (tight blood pressure control). - Standard of care alone with tight blood pressure control. Renal function after 6 months is the primary evaluation criterium. HE is a frequently associated with aHUS, and strongly impacts patient renal prognosis. Efficient therapeutic strategies are still lacking for this condition. The HYPERSHU study will allow to evaluate the benefit of early Eculizumab therapy in patients with HE-aHUS and severe renal dysfunction.

NCT ID: NCT05711264 Not yet recruiting - Clinical trials for Autoimmune Hemolytic Anemia

Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.

Start date: January 30, 2023
Phase:
Study type: Observational

1. Study the presence of circulating CD4+/CD28 null T lymphocytes in AIHA either Idiopathic or Secondary. 2. Role of CD4+/CD28 null T lymphocytes in monitoring response to therapy in AIHA.

NCT ID: NCT05694312 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL

Start date: November 24, 2023
Phase: Phase 2
Study type: Interventional

This is a multicenter, single arm, phase II study aimed at evaluating ibrutinib therapy for the treatment of AIHA in patients with CLL/SLL or CLL-like MBL.

NCT ID: NCT05684159 Not yet recruiting - Clinical trials for aHUS - Atypical Hemolytic Uremic Syndrome

Study of NM8074 in Patients With aHUS With Evidence of Ongoing Thrombotic Microangiopathy

Start date: October 2024
Phase: Phase 2
Study type: Interventional

This is a Phase II, open-label study designed to determine if intravenously administered NM8074 results in remission from TMA in treatment-naïve aHUS patients.

NCT ID: NCT05676697 Terminated - Clinical trials for Autoimmune Hemolytic Anemia

PI3K Delta Inhibitor in Relapsed / Refractory Autoimmune Hemolytic Anemia Patients After Receiving Two or More Lines of Therapy

Start date: January 13, 2023
Phase: Phase 1
Study type: Interventional

This is a prospective, multicenter, single-arm, pilot study. The aim of this study is to evaluate the efficacy and safety of Linperlisib, the PI3K delta inhibitor for autoimmune hemolytic anemia patients who failed the second line therapy.

NCT ID: NCT05648968 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia (wAIHA)

A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia

VAYHIA
Start date: December 30, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.

NCT ID: NCT05647200 Not yet recruiting - Clinical trials for Endothelial Dysfunction

Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part II

PRIME part II
Start date: October 15, 2023
Phase: N/A
Study type: Interventional

Acute microcirculatory perfusion disturbances is common in critical illness and associated with increased morbidity and mortality. Recent findings by our group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to forty two percent, 42%) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.

NCT ID: NCT05647057 Recruiting - Clinical trials for Endothelial Dysfunction

Optimization of Prime Fluid Strategy to Preserve Microcirculatory Perfusion During Cardiac Surgery With Cardiopulmonary Bypass, Part I

PRIME part I
Start date: June 15, 2023
Phase: N/A
Study type: Interventional

Acute microcirculatory perfusion disturbances is common in critical illness and associated with higher morbidity and mortality. Recent findings by the investigators' group showed that microcirculatory perfusion is disturbed during cardiac surgery with cardiopulmonary bypass (CPB) and remain disturbed up to 72 (seventy two) hours after surgery. A cardiopulmonary bypass is a machine which takes over heart and lung function, during the procedure. The disturbed microcirculation is associated with organ dysfunction induced by cardiac surgery using CPB, which is frequently seen (up to 42%, forty two percent) and results in a six-fold increase in mortality rate. The underlying cause of disturbed microcirculation is a higher endothelial permeability and vascular leakage and are a consequence of systemic inflammation, hemodilution (dilution of blood), hypothermia and hemolysis (breakdown of red blood cells). To gain the knowledge regarding disturbed microcirculation the investigators previously showed that hemodilution attributes to this disturbed perfusion. Hemodilution lowers colloid oncotic pressure (COP). Also, COP is affected by free hemoglobin, which increases with hemolysis and attributes to a disturbed microcirculation following CPB. This is interesting, as to the best of our knowledge, the effect of minimizing hemodilution and hemolysis during cardiac surgery on the microcirculatory perfusion has never been investigated, but could be the key factor in reducing organ dysfunction.