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Hemolysis clinical trials

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NCT ID: NCT06198933 Not yet recruiting - Atrial Fibrillation Clinical Trials

Renal Function and Hemolysis After Pulsed-field Ablation for Atrial Fibrillation

Start date: February 1, 2024
Phase:
Study type: Observational

The aim of the project is to assess hemolysis and renal function after catheter ablation for atrial fibrillation using pulsed-field energy. Hemolysis will be determined using the concentration of red blood cell microparticles at the end of the ablation (when all ablation were done, before sheath removal). Hemoglobinuria will be assessed one day after the procedure. Renal functions will be assessed one and three day after the procedure using standard parameters (creatinine, urea). The goal is to assses the acute worsening fo renal functions after pulsed-field ablation in relation to the number of PF applications, and to the degree of immediate post-procedural hemolysis.

NCT ID: NCT06144801 Completed - Pain Clinical Trials

The Effect of Coolsense Method on Pain and Comfort in Hemodialysis Patients

Start date: February 20, 2023
Phase: N/A
Study type: Interventional

This study aimed to investigate the impact of the CoolSense method on arteriovenous fistula cannulation pain and the comfort levels of hemodialysis patients.

NCT ID: NCT06099236 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome(aHUS)

A Prospective, Non-interventional, Observational Study of Presentation, Treatment Patterns and Outcomes in Atypical Hemolytic Uremic Syndrome Patients

Start date: January 15, 2024
Phase:
Study type: Observational

This is a China, non-interventional, observational study and will follow the Good Phar-macoepidemiology Practices guidelines. This study will enrol paediatric and adult patients diagnosed with aHUS who will be treated according to routine clinical practice defined by local institutional treatment guidelines/protocol. Those aHUS patients who will be treated with a supportive therapy, which does not contain eculizumab, will be monitored for up to 12 months since the ini-tial diagnosis. Patients initiated on eculizumab treatment anytime between aHUS diagno-sis until 12 months will be followed for additional 12 months, starting from the ecu initia-tion. Patient disposition, characteristics, outcomes and safety will be described for all pa-tients enrolled into this study

NCT ID: NCT06096428 Not yet recruiting - Atrial Fibrillation Clinical Trials

Hemolysis During Pulsed-field and Radiofrequency Ablation

Start date: November 15, 2023
Phase:
Study type: Observational

Hemolysis during and after catheter ablation will be compared between catheter ablation performed using radiofrequency and pulsed-field energy. Consecutive patients indicated for catheter ablation for AF will be enrolled, catheter ablation will be done using standard catheters (Qdot, Biosense Webster for RF, and Farapulse, Boston-Scientific for PF). Blood samples will be drawn at the beginning of ablation (T1), at the end of ablation (T2), and one day after the procedure (T3). Hemolysis will be analyzed using flow cytometry, ELISA and standard biochemistry and compared between RF and PF patients, Primary hypothesis is that hemolysis level will be higher after PF ablation compared to RF ablation.

NCT ID: NCT06021977 Recruiting - Clinical trials for Refractory/Relapsed Autoimmune Hemolytic Anemia

The Safety and Efficacy of Zanubrutinib in Refractory/Relapsed Autoimmune Hemolytic Anemia

Start date: September 1, 2023
Phase: Phase 2
Study type: Interventional

The sample size of this study is calculated based on Simon's two-stage design. The first stage of the study enrolled a cohort of 12 patients. If after 12 weeks at least 6 patients achieved a response, then enrollment was expanded to a total of 26 patients. The null hypothesis was unaccepted if more than 14 of 26 patients achieved the response. Accounting for a 20% dropout rate, the estimated final sample size was 33 patients.

NCT ID: NCT05991245 Recruiting - Acute Kidney Injury Clinical Trials

French National Cohort MATRIX "Renal and Systemic Thrombotic Microangiopathy"

MATRIX
Start date: January 1, 2023
Phase:
Study type: Observational

Thrombotic microangiopathies (TMAs) are a diverse, rare but serious group of diseases. Progress has been made regarding the epidemiology of TMA (Bayer CJASN 2019). It has been shown that secondary TMAs account for 95% of cases, whereas primary TMAs (atypical hemolytic syndromes (HUS) and thrombotic thrombocytopenic purpura (TTP)) account for only about 5%. However, in many cases, the pathophysiology, optimal management and prognosis of TMA remains unclear and it has been shown that patients with TMA may have renal-limited TMA or renal and hematological TMA (ie. With (mechanical anemia, thrombocytopenia, elevated LDH, decreased haptoglobin, schistocytes). In most studies, kidney biopsies are not performed and the diagnostic workup is uncomplete. As this is a rare disease, only a multicenter approach (>20 centers) over a long period of time (>10 years), with adequate diagnostic workup including kidney biopsies can help us to answer these questions (investigators in the present are usually members of the CNR-MAT (a network of the TMA centers in France).

NCT ID: NCT05982938 Available - Clinical trials for Paroxysmal Nocturnal Hemoglobinuria

Danicopan Early Access Program

Start date: n/a
Phase:
Study type: Expanded Access

This is an EAP, designed to provide early access to danicopan for participants with PNH experiencing clinically significant EVH who have failed, not tolerated, or are unable to receive other approved treatments; in the Treating Physician's opinion, the participant is not eligible for or is not able to participate in an ongoing clinical trial of danicopan or a comparable treatment; and according to the Treating Physician, the benefit of danicopan treatment outweighs the potential risks.

NCT ID: NCT05962268 Completed - Hemolysis Clinical Trials

The Effect Of Vıdeo-Based Fıstula Care Educatıon On Hemodıalysıs

Start date: October 1, 2022
Phase: N/A
Study type: Interventional

Objective: This study aimed to determine the effect of face-to-face and video-based education for fistula care on hemodialysis patients' self-care behaviors. Methods: The study was conducted as a randomized controlled experimental study. Fistula care training was given to the patients in the control group using face-to-face education technique. Fistula care training was given to the patients in the experimental group using a video based technique.

NCT ID: NCT05935215 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

Efficacy and Safety of Switching From Anti-C5 Antibody Treatment to Iptacopan Treatment in Study Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Start date: February 28, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to evaluate the efficacy and safety of iptacopan upon switching from anti-C5 antibody to iptacopan treatment in study participants with aHUS.

NCT ID: NCT05931718 Recruiting - Clinical trials for Myelodysplastic Syndromes

Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia

AIHA ITP CIN
Start date: June 1, 2021
Phase:
Study type: Observational

The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia. The main aims to answer are: - evaluation of traditional and novel diagnostic tools including immunohematology, cytokine essays, bone marrow studies, molecular findings, and fecal microbiome. - evaluation of type and sequence of the therapies administered, the response rates, and the adverse events. - evaluation of clinical and laboratory (immunologic, molecular, and morphologic) predictors of outcome. - evolution of autoimmune cytopenias into myelodysplastic syndromes. - a subgroup of patients with myelodysplastic syndromes will be included to evaluate the presence of immunologic events, autoimmune activation, and red cell metabolism. Participants will receive a clinical/laboratory diagnostic workup as per current clinical practice. Furthermore They will be sampled at baseline (peripheral blood and feces for microbiome) and followed up for at least 3 years to evaluate their clinical course, therapeutic management and outcome.