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Hemolysis clinical trials

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NCT ID: NCT02949128 Completed - Clinical trials for Atypical Hemolytic Uremic Syndrome (aHUS)

Study of ALXN1210 in Complement Inhibitor Treatment-Naïve Adult and Adolescent Participants With Atypical Hemolytic Uremic Syndrome (aHUS)

Start date: January 11, 2017
Phase: Phase 3
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of ravulizumab to control disease activity in adolescent and adult participants with aHUS who had not previously used a complement inhibitor.

NCT ID: NCT02924792 Completed - Hemorrhagic Shock Clinical Trials

Sternal Intraosseous Transfusion of Autologous Whole Blood: A Comparison of Flow Rates and Degree of Hemolysis

Start date: November 2016
Phase: N/A
Study type: Observational

In this study the impact of two CE marked and FDA approved sternal needles in comparison to intravenous access on the flow-rate of autologous reinfusion of whole blood and the possible hemolysis of red cells post-transfusion in a population of healthy military officers is investigated.

NCT ID: NCT02904863 Completed - Clinical trials for Hemolytic Uremic Syndrome

Study of 'Vascular Competence' Profile and Endothelial Activation in the Hemolytic Uremic Syndrome in Children and Adults

SHU
Start date: February 11, 2013
Phase: N/A
Study type: Interventional

The Hemolytic Uremic Syndrome (HUS) is a rare thrombotic microangiopathy (TMA), affecting both children and adults. HUS is characterized by the abnormal occurrence of diffuse thrombosis in the microcirculation resulting in the occurrence of ischemic events affecting especially the kidneys and is associated with hemolytic anemia. One of the major problems encountered in the management of HUS is the absence of reliable marker of treatment response or relapse; conventional hematological markers being too insensitive to judge therapeutic efficacy or identify early relapse. Data from the literature suggest that the endothelial cell is a major target of this syndrome. Our hypothesis is that an initial micro-endothelial activation plays a critical role in the initiation and / or relapse of the disease.The main objective of this study is to define a "vascular competence" profile in a population of patients with typical or atypical HUS; both in the acute phase and in remission of the disease.

NCT ID: NCT02711332 Completed - Hemolysis Clinical Trials

Investigating the Influence of Haemolysis on the Potassium Concentration After Capillary Blood Sampling

Start date: June 2015
Phase: N/A
Study type: Observational

This is an open, single-centre trial investigating the impact of haemolysis after capillary blood collection to the measured potassium concentration in Plasma healthy subjects. Each subject will have four capillary blood collections on different fingers. Two on the right and two on the left hand. Additionally as a reference a venous blood collection will be conducted.

NCT ID: NCT02689986 Completed - Clinical trials for Autoimmune Hemolytic Anemia

Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease

CAD5
Start date: January 2013
Phase: Phase 2
Study type: Interventional

Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.

NCT ID: NCT02612558 Completed - Clinical trials for Warm Antibody Autoimmune Hemolytic Anemia

A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)

SOAR
Start date: July 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

NCT ID: NCT02574403 Completed - Clinical trials for Atypical Hemolytic Uremic Syndrome

Study Assessing an Algorithm-based Strategy of Eculizumab Discontinuation in Children and Adults With aHUS

STOPECU
Start date: November 2015
Phase: Phase 4
Study type: Interventional

Atypical hemolytic syndrome (aHUS) is a severe renal disease affecting children and adults. It is characterized by the occlusion of intrarenal vessels due to the presence of platelet/fibrin thrombi, and leads to end-stage renal disease in up to 2/3 of patients. The discovery of complement alternative pathway as a major risk factor for aHUS has led to the design of a disease-specific treatment, the anti-C5 monoclonal antibody, eculizumab. Complement inhibition using eculizumab has clearly improved the renal outcome of aHUS patients with a dramatic decrease in the risk of end-stage renal disease. However, the optimal duration of eculizumab therapy is still debated. The present study aims to assess the feasibility and safety of the discontinuation of eculizumab treatment in children and adults with aHUS.

NCT ID: NCT02389231 Completed - Clinical trials for Autoimmune Hemolytic Anemia

Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment

ANEMIL
Start date: May 17, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is correlated to hemoglobin levels. In vitro, low dose of interleukine-2 (IL2) induce the expansion of CD8 Tregs. The objective is to demonstrate that, over a 9 week treatment period; low doses of IL2 can induce the expansion of CD8Tregs in patients with active wAHAI.

NCT ID: NCT02259478 Completed - Hemolysis Clinical Trials

Isoagglutinins in the Development of IVIG-associated Hemolysis

Start date: October 2014
Phase: N/A
Study type: Observational

Patients at high risk of IVIG-associated hemolysis (defined as receipt of a 28-day cumulative dose of ≥ 2 g/kg, adjusted for ideal body weight, and non-O blood group) will be prospectively monitored using a standardized protocol for signs of hemolysis, and will be undergo additional testing for variables that have been hypothesized to increase the risk of hemolysis. The goal of the study is to define the incidence and dynamics of IVIG-mediated hemolysis and identify patient and product-related factors that may predict which patients are especially at risk.

NCT ID: NCT02216123 Completed - Malaria, Vivax Clinical Trials

Study to Assess the Incidence of Hemolysis, Safety, and Efficacy of Tafenoquine (SB-252263, WR238605) Versus Primaquine in Subjects With Plasmodium Vivax Malaria

Start date: April 30, 2015
Phase: Phase 3
Study type: Interventional

This is a prospective, double-blind, double-dummy, multicenter, comparative study. A total of 300 subjects will be randomized to treatment on Day 1, of which a minimum of 50 female subjects must be enrolled that display moderate glucose-6-phosphate dehydrogenase (G6PD) deficiency (>=40% - <70% of the site median G6PD value). Subjects must have a blood smear that is positive for P. vivax at entry. Subjects will be randomized 2:1 to receive tafenoquine (TQ)/chloroquine(CQ) or the active comparator primaquine (PQ)/CQ. All subjects will receive CQ on Days 1 to 3, followed by TQ or PQ and matching placebo beginning on Day 1 or 2. Tafenoquine, or matching placebo, will be given as a single, 300mg dose. Subjects will receive PQ (15mg once daily) or matching placebo for 14 days. The duration of the study is 180 days, including screening and randomization to treatment (Day 1), three in-hospital days (Days 1-3), four out-patient visits while on treatment with study medication (Days 5, 8, 11 and 15) and seven follow-up visits (Days 22, 29, 60, 90, 120, 150 and 180). The primary safety data collected in this study will help to understand the hemolysis risk to both G6PD-normal and G6PD-deficient subjects. The efficacy data produced from this study will support the results for sister study TAF112582, the pivotal phase III efficacy and safety study of the TQ program.