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Hemolysis clinical trials

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NCT ID: NCT04902833 Recruiting - Clinical trials for Acute Myeloid Leukemia

Acquired Pyruvate Kinase Deficiency In Clonal Myeloid Neoplasms

Start date: February 1, 2022
Phase:
Study type: Observational

This cross-sectional prevalence assessment study involves a single blood draw in specific patient populations to assess for enzymatic and genomic evidence for acquired pyruvate kinase deficiency.

NCT ID: NCT04889430 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

Efficacy and Safety of Iptacopan (LNP023) in Adult Patients With Atypical Hemolytic Uremic Syndrome Naive to Complement Inhibitor Therapy

APPELHUS
Start date: January 17, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this Phase 3 study is to determine whether iptacopan (LNP023) is efficacious and safe for the treatment of aHUS in adult patients who are treatment naive to complement inhibitor therapy.

NCT ID: NCT04861259 Recruiting - Clinical trials for Atypical Hemolytic Uremic Syndrome

A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

COMMUTE-a
Start date: October 22, 2021
Phase: Phase 3
Study type: Interventional

This study aims to evaluate the efficacy and safety of crovalimab in adult and adolescent participants with aHUS.

NCT ID: NCT04745195 Recruiting - Clinical trials for Thrombotic Microangiopathies

Complement Prospective Evaluation of Thrombotic Microangiopathy on Endothelium

COMPETE
Start date: August 12, 2021
Phase:
Study type: Observational [Patient Registry]

Thrombotic microangiopathy (TMA) is a severe and life-threatening condition, often affecting the kidneys and brain. It can occur on the background of various clinical conditions. Dysregulation of the alternative pathway of complement may be the etiological factor and this type of TMA is classified, according to the current nomenclature, as primary atypical hemolytic uremic syndrome (HUS). Half the patients with primary atypical HUS present with rare variants in complement genes, although coexisting conditions are often needed for the TMA to become manifest. In patients with secondary atypical HUS, certain coexisting conditions appear to drive the disease and treatment should target the underlying condition to remit the TMA. Recently, the investigators demonstrated, by using a novel in-house developed functional endothelial cell-based test, that complement dysregulation and overactivation is the dominant cause of disease and its sequelae in a subset of patients with secondary atypical HUS, having impact on treatment and prognosis. The investigators did first prove this concept in patients presenting with TMA and hypertensive emergency. A prospective study is needed to further corroborate these findings along the spectrum of TMA. The investigators hypothesize that their functional endothelial cell-based test, the so-called "HMEC" test, can better categorizes the TMA into different groups with potential therapeutic and prognostic implications. Thus, paving the road to the ultimate goal of precision medicine.

NCT ID: NCT04398459 Recruiting - Clinical trials for Refractory/Relapsed Autoimmune Hemolytic Anemia

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

Start date: May 1, 2020
Phase: Phase 2
Study type: Interventional

This is an open-label, single-arm study to evaluate the safety and efficacy of Ibrutinib in subjects with refractory/relapsed autoimmune hemolytic anemia.

NCT ID: NCT04218318 Recruiting - Clinical trials for Neonatal Hyperbilirubinemia

Safe Threshold to Discontinue Phototherapy in Hemolytic Disease of Newborn

Start date: October 1, 2019
Phase: N/A
Study type: Interventional

We hypothesized that adopting a lower rather than a higher threshold for phototherapy discontinuation will be associated with reduced rates of rebound hyperbilirubinemia in term and late preterm neonates with hemolytic disease of newborn. Objectives: The investigators aimed to compare the safety of implementing low-threshold, compared to high- threshold, of TSB for phototherapy interruption in term and late preterm neonates with hemolytic disease of newborn.

NCT ID: NCT04119050 Recruiting - Clinical trials for Warm Autoimmune Hemolytic Anemia

Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

ENERGY
Start date: August 15, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

NCT ID: NCT04024202 Recruiting - Clinical trials for Autoimmune Hemolytic Anemia

Data Registry of Auto Immune Hemolytic Anemia

DRAIHA
Start date: July 12, 2019
Phase:
Study type: Observational

In autoimmune hemolytic anemia (AIHA) auto-antibodies directed against red blood cells (RBCs) lead to increased RBC clearance (hemolysis). This can result in a potentially life-threatening anemia. AIHA is a rare disease with an incidence of 1-3 per 100,000 individuals. An unsolved difficulty in diagnosis of AIHA is the laboratory test accuracy. The current 'golden standard' for AIHA is the direct antiglobulin test (DAT). The DAT detects autoantibody- and/or complement-opsonized RBCs. The DAT has insufficient test characteristics since it remains falsely negative in approximate 5-10% of patients with AIHA, whereas a falsely positive DAT can be found in 8% of hospitalized individuals. Also apparently healthy blood donors can have a positive DAT. The consequences of DAT positivity are not well known and may point to early, asymptomatic disease, or to another disease associated with formation of RBC autoantibodies, such as a malignancy or (systemic) autoimmune disease. Currently, there are no guidelines to follow-up DAT positive donors. A second unsolved difficulty is the choice of treatment in AIHA. Hemolysis can be stopped or at least attenuated with corticosteroids, aiming to inhibit autoantibody production and/or RBC destruction. Many patients do not respond adequately to corticosteroid treatment or develop severe side effects. Currently, it is advised to avoid RBC transfusions since these may lead to aggravation of hemolysis and RBC alloantibody formation. But in case symptomatic anemia occurs, RBC transfusions need to be given. An evidence-based transfusion strategy for AIHA patients is needed to warrant safe transfusion in this complex patient group. To design optimal diagnostic testing and (supportive) treatment algorithms, the investigators will study a group well-characterized patients with AIHA and blood donors without AIHA, via a prospective centralized clinical data collection and evaluation of new laboratory tests. With this data the knowledge of the AIHA pathophysiology and to evaluate diagnostic testing in correlation with clinical features and treatment outcome can be improved.

NCT ID: NCT03748082 Recruiting - Clinical trials for Cardiovascular Diseases

Effects of Nitric Oxide on the Endothelium During Hemolysis.

Start date: December 5, 2018
Phase: Phase 2
Study type: Interventional

This study is an ancillary (add-on) study to the clinical trial entitled "Effect of Nitric Oxide in Cardiac Surgery Patients With Endothelial Dysfunction", which has Clinical Trials.gov identifier NCT02836899. NCT02836899 trial randomizes cardiac surgical patients to receive either Nitric Oxide (NO) or a placebo during and after cardiac surgery. This ancillary study aims to assess the effects of Nitric Oxide on vascular responsiveness and on endothelial function during hemolysis in patients with pre-operative endothelial dysfunction undergoing cardiac surgery requiring prolonged cardiopulmonary bypass.

NCT ID: NCT03633435 Recruiting - Nurse's Role Clinical Trials

Home Hemodialysis Assisted by a Nurse for Arterio-venous Fistula Cannulation

DIADIDEAL
Start date: March 21, 2019
Phase: N/A
Study type: Interventional

Home HD (HHD) is associated with better outcome in end-stage renal disease patients compared to in-center HD, in particular in terms of quality of life. However fear of AVF cannulation is a known barrier for patient's choice and adoption of a HHD program. Providing nurse assistance for the cannulation can help developing HHD programs. The aim of this study is to evaluate the feasibility of assisted home hemodialysis, with the intervention of a nurse at home for arterio-venous fistula cannulation.