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Hemolysis clinical trials

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NCT ID: NCT01345708 Completed - Clinical trials for Autoimmune Hemolytic Disease (Cold Type) (Warm Type)

A Single-Arm Pilot Study With Low-Dose Rituximab Plus Standard Oral Prednisone In Idiopathic Autoimmune Hemolytic Anemia

Start date: January 2009
Phase: Phase 2
Study type: Interventional

The aim of this prospective study was to evaluate the activity, safety and the duration of the response of low dose rituximab associated with standard oral prednisone as first line therapy in newly diagnosed warm autoimmune hemolytic anemia and cold hemagglutinin disease, and as second line therapy in warm autoimmune hemolytic anemia relapsed after standard oral prednisone. Further aim was to correlate the clinical response to biological parameters (cytokine and anti-erythrocyte antibody production in cultures).

NCT ID: NCT01316796 Completed - Sickle Cell Disease Clinical Trials

Topical Sodium Nitrite for Chronic Leg Ulcers in Adult Patients With Blood Disorders

Start date: March 15, 2011
Phase: Phase 1
Study type: Interventional

Background: - Chronic leg ulcers are a complication of many blood disorders such as sickle cell disease, thalassemia, and other red blood cell disorders. In these disorders, red blood cells break down earlier than normal, which researchers suspect may cause or contribute to the development of leg ulcers; however, the exact cause is unknown, and current therapies are not very effective. Researchers are interested in determining if a research cream made with sodium nitrite, a substance that is known to increase blood flow by dilating blood vessels, may speed up the healing of skin ulcers. Objectives: - To evaluate the safety and effectiveness of topical sodium nitrite cream as a treatment for chronic leg ulcers in individuals with sickle cell disease or other red blood cell disorders. Eligibility: - Individuals at least 18 years of age who have sickle cell disease or another red cell disorder and have had a leg ulcer for more than 4 weeks. Design: - Participants will be screened with a physical examination, medical history, blood tests, and an examination of the ulcer, including x-ray of the leg(s) with the ulcer and swabs from the wound. - Participants will be scheduled for a 5-day inpatient stay at the Clinical Center, with the following procedures: - Days 1 and 2: Participants will have blood draws, a wound assessment, ultrasound of the affected leg, imaging studies (magnetic resonance imaging and infrared photography), thermo-patch application to monitor temperature changes, measurements of blood flow in the skin, and questionnaires about pain and quality of life. An optional skin biopsy may also be conducted with samples taken near the skin ulcer - Day 3: Participants will have one ulcer treated with the topical cream. Frequent blood draws will be conducted before application and then regularly for up to 6 hours after application of the cream. Thirty minutes after the research cream is applied, participants will have imaging studies of the treated leg and measurements of pain levels and blood flow. - Day 4: Participants will have a blood draw and temperature recordings taken. - Day 5: Participants will have the research cream applied and the same imaging studies as before, and will be discharged for care at home. - For the following 3 weeks, participants will come to the clinical center twice a week to have the research cream applied to the leg ulcer and tests performed by the study researchers. - For the fourth and final week, participants will return for additional cream treatment sessions, imaging studies, blood draws, and other tests as directed by the study researchers. - Study participation will end in the following week (week 5). Subjects will come for a final visit one month after the end of the study.

NCT ID: NCT01290458 Completed - Oxidative Stress Clinical Trials

The Effect of Antioxidant Vitamin Supplementation on Muscle Performance and Redox Status After Eccentric Training

Start date: June 2009
Phase: N/A
Study type: Interventional

Consumption of vitamin supplements is a common practice among athletes or people participating in health promoting exercise programs. The reason for this interest in vitamin supplements is primarily because of the observation that enhanced production of reactive oxygen and nitrogen species (RONS) influence fundamental biological processes, such as gene expression, signal transduction and enzyme activity. In a muscle and exercise physiology context, a low level of RONS is required for normal force production, whereas marked increases in RONS can cause contractile dysfunction, resulting in muscle weakness and fatigue. On the other hand RONS are involved in signaling pathways and serve to up-regulate the expression of a number of genes and can exert favorable effects such as training adaptations. The present study will employ a valid eccentric exercise model to examine the influence of combined vitamin C and E supplementation after acute and chronic eccentric exercise on muscle damage and performance, redox status, hemolysis and lipid and lipoprotein profile.

NCT ID: NCT01194973 Completed - Clinical trials for Atypical Hemolytic-Uremic Syndrome

An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

Start date: July 2010
Phase: Phase 2
Study type: Interventional

The record Primary purpose is to assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

NCT ID: NCT01193348 Completed - Clinical trials for Atypical Hemolytic-Uremic Syndrome

An Open-Label, Multi-Center Clinical Trial of Eculizumab in Pediatric Patients With Atypical Hemolytic-Uremic Syndrome

aHUS
Start date: September 2010
Phase: Phase 2
Study type: Interventional

The primary purpose is to assess the efficacy and safety of eculizumab in pediatric patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.

NCT ID: NCT01181154 Completed - Clinical trials for Warm Autoimmune Hemolytic Anemia

Rituximab in Auto-Immune Hemolytic Anemia

RAHIA
Start date: March 3, 2011
Phase: Phase 3
Study type: Interventional

The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be include (amendment n°6 - 15/10/2013) over a 3 year period (amendment n°3 - 11/12/2012).

NCT ID: NCT01134432 Completed - Clinical trials for Anemia, Hemolytic, Autoimmune

Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia

Start date: March 2005
Phase: Phase 3
Study type: Interventional

The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the gradual reduction in dose of the drug. As a result, many patients will finally be splenectomized or be treated with long-term glucocorticoids or other immunosuppressive drugs as azathioprine or cyclophosphamide. Recent studies have shown however, that some patients will respond to treatment with the chimeric anti-CD 20 antibody Rituximab and is some cases, the response is permanent. In most of the studies, Rituximab has been used in refractory disease or at least as second line treatment. In this study, patients with AIHA are randomized to receive either high-dose prednisolone with gradual reduction in dose over 2-3 months alone or in combination with Rituximab 375 mg/m2 once a week for 4 weeks. The efficacy of Rituximab will be evaluated by a comparison of the patients in the two treatment arms. The primary treatment goal is a reduction in the number of patients who obtain long-term complete or partial remission. The secondary treatment goal is a reduction in patients who will be splenectomised or receive other immunosuppressive drugs. Finally a comparison of side effects of the treatments will take place.

NCT ID: NCT01048905 Completed - Sickle Cell Disease Clinical Trials

Glutamine Therapy for Hemolysis-Associated Pulmonary Hypertension

Start date: March 2009
Phase: Phase 2
Study type: Interventional

The primary hypothesis of this study is that glutamine supplementation will improve the erythrocyte glutamine/glutamate ratio, a biomarker of oxidative stress, hemolysis and pulmonary hypertension (PH) in sickle cell disease (SCD) and thalassemia (Thal) patients with PH. PH is defined as a tricuspid regurgitant jet velocity (TRV) on Doppler echocardiography > 2.5 m/s. We also predict that glutamine therapy will increase arginine bioavailability and subsequently alter sickle red cell endothelial interaction that can be identified using endo-PAT technology through nitric oxide (NO) generation, leading to changes in biological markers, and clinical outcome. Specifically our second hypothesis is that oral glutamine will decrease biomarkers of hemolysis and adhesion molecules, and improve the imbalanced arginine-to-ornithine ratio that occurs in hemolytic anemias, leading to improved arginine bioavailability and clinical endpoints of endothelial dysfunction and PH in patients with SCD and Thal.

NCT ID: NCT00930423 Completed - Clinical trials for Atypical Hemolytic Uraemic Syndrome

Complement Activation During Hemodialysis in Atypical Hemolytic Uraemic Syndrome as Underlying Kidney Disease

Start date: August 2009
Phase:
Study type: Observational

Atypical hemolytic uraemic syndrome is caused by defects in the regulating factors in the alternative pathway of the complement system. Triggering can cause an uncontrolled complement activation with endothelial damage and thrombotic micro-angiopathy, especially in the kidneys. This can result in endstage renal failure. Complement activation during hemodialysis has been described as a result of contact between blood and the dialysis membrane. Our hypothesis is that patients with atypical hemolytic uraemic syndrome have a stronger complement activation during hemodialysis than patients with another underlying kidney disease. This could be a reason to treat patients with endstage renal failure due to atypical hemolytic uraemic syndrome preferentially with peritoneal dialysis instead of hemodialysis.

NCT ID: NCT00891787 Completed - Probiotic Toxicity Clinical Trials

Probiotic Ingestion and Isoagglutinin Titers

Start date: April 28, 2009
Phase: Phase 1
Study type: Interventional

Background: - Probiotics are oral food supplements containing live bacteria that may be beneficial to a person s digestion or general health. Probiotics are available as tablets, powder, or liquid supplements and are frequently used to supplement yogurt. They are available for purchase without prescription in most supermarkets. - The bacteria in probiotic supplements commonly express sugar substances on their surface. These sugar substances are similar to group A and B blood group sugars, called antigens. These antigens determine a person s blood group. Researchers are studying the effect of probiotic supplements on the amount of blood group antibodies that are present in a person s blood. Objectives: - To determine whether taking oral probiotic supplements increases anti-A and anti-B isoagglutinins (antibodies that cause red blood cells to clump together) in healthy subjects. - To study the frequency of these effects and determine whether there is a dose-response relationship with probiotics and isoagglutinin titers. Eligibility: - Healthy adults, 18 years or older, with type A, B, or O blood. - Female participants need to have undergone menopause or have had a hysterectomy. - Individuals are ineligible if they currently donate platelets; have a history of ulcerative colitis or Crohn s disease; have had major bowel surgery; are pregnant or capable of becoming pregnant; have a bleeding or clotting disorder; have a history of a blood disorder or immune deficiency; have a history of high-risk behaviors for exposure to HIV or hepatitis B or C; have diabetes; have received vaccinations in the past 2 months, with the exception of the flu vaccine; are currently taking immunosuppressive medications; are currently taking antibiotics; or have taken probiotic supplements within the last 12 months. Design: - Researchers will conduct the following tests throughout the 28-week study: - Blood samples will be drawn every 2 weeks to measure the quantity of isoagglutinin titers. - Depending on individual results, continued blood testing may be done every 3 months for 1 year, then every 6 to 12 months for up to 5 years. - Study subjects will take a probiotic supplement at a dose of 1 to 3 caplets per day for 18 consecutive weeks according to the following schedule: - During the first 6-week period, the subject will take one probiotic tablet daily. - During the second 6-week period, the subject will take one probiotic tablet twice daily. - During the third 6-week period, the subject will take one probiotic tablet three times daily. - Control group subjects will be followed in a similar manner but will not take probiotic supplements. - The outcome measure is the percent of probiotic ingestors (the study subjects) versus control group subjects who experience a fourfold or greater rise in isoagglutinin titer. - Study subjects will receive the following financial compensation: $10 per blood sample, for a maximum of $240 if all 24 samples are collected; $100 after completing the first 6-week period; $150 after completing the second 6-week period; and $200 after completing the third 6-week period. - Control subjects will receive $10 per blood sample, for a maximum of $150 if all 15 samples are collected.