View clinical trials related to Anemia.
Filter by:Phase III, multicentre, double-blind, randomised, parallel, equivalence clinical trial to determine the efficacy, safety and immunogenicity of Megalabs® recombinant human alfa epoetin for subcutaneous use, compared to Eprex® (Janssen-Cilag Farmacêutica Ltda.), in the treatment of anaemia in participants with chronic renal disease, dependent on haemodialysis
The goal of this observational study is to learn about the costs that occur when participants with severe anemia are treated with blood transfusions or with patient blood management (PBM). PBM means that the body of the participant is stimulated to produce new blood by itself rather than receiving it from a blood donor, and to reduce blood losses. The main question the study aims to answer is: Do participants treated with transfusions incur the same treatment costs than participants treated with PBM? And how much costs are this in relation to the lives saved by the therapy of severe anemia?
The goal of this observational cohort study is to compare patients with very low red blood counts who receive different therapy. Its main question[s] it aims to answer are: - Which group of patients dies more frequent: Patients who receive patient blood management only, patients who receive patient blood management and transfusions or patients who receive only transfusions? - Among these groups: which group of patients has more complications during hospital stay? Patients will either receive patient blood management, which is the management of anemia, bleeding and coagulation problems, will receive transfusions, that is, blood from other people, or a mix of both.
Methemoglobinemia as a side effect of treatment with intravenous iron has not previously been described. This study aims to assess methemoglobin levels in patients with anemia following treatment with intravenous iron, administered as ferric carboxymaltose or ferric derisomaltose.
POAM is a multicenter, randomized, controlled, internal pilot trial, using a conventional, parallel group, two-armed design at 3 cardiac surgery centres in Canada. The study is designed to assess the feasibility of a future, definitive RCT investigating whether, in patients with chronic iron-deficiency anemia undergoing cardiac surgery, IV iron therapy in the postoperative period (initiated shortly after surgery, and repeated at 42 days after surgery, if needed) improves clinical outcomes (days alive and out of hospital at 90 days after surgery; DAOH-90) relative to placebo.
This is a multicenter, single-arm, non-interventional study (NIS) to confirm the safety and efficacy of eltrombopag in Anti-Thymocyte Globulin (ATG) treatment naive pediatric patients with aplastic anemia (AA).
To look at the safety and effectiveness of emapalumab for the treatment of prolonged severe cytopenia in participants with LBCL who receive CART.
The goal of this observational study is to evaluate the clinical efficacy of the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells, and to study the changes of inflammatory response before and after the transfusion of irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells in anemic neonates. The main questions it aims to answer are: - Objective evaluation of the advantages and disadvantages of transfusion of different blood products in the treatment of neonatal anemia from the clinical efficacy. - To provide objective basis for clinical rational use of blood in the selection of blood products. Participants will be transfused with fresh irradiated red blood cells, washed red blood cells, and leukocyte privative red blood cells respectively according to relevant clinical and laboratory indicators.
The aim of this prospective, observational cohort study is to assess the impact of iron deficiency anaemia on the incidence of perioperative complications and the quality of recovery after surgery in patients undergoing colorectal cancer surgery. The main questions the study aims to answer are: - whether the presence of preoperative iron deficiency anaemia leads to a poorer quality of postoperative recovery in patients undergoing colorectal cancer surgery - whether different combinations of complete blood count parameters (red blood cell indices) could be suitable diagnostic tools for the detection of iron deficiency in the latent stage (without laboratory-confirmed anaemia) in colorectal cancer patients. Blood samples for laboratory analyses will be collected from each study patient admitted to the surgical ward one day prior to elective surgery and on the first postoperative day during the stay in the intensive care unit. The pre-operative laboratory analyses include a complete blood count and serum iron status parameters (iron concentration, ferritin concentration, TIBC, UIBC and TSAT). Laboratory parameters analysed on the first postoperative day include complete blood count, serum concentration of electrolytes (Na, K, Ca, Cl, Mg), serum concentration of urea and creatinine, parameters of haemostasis (aPTT, PT, INR), serum concentration of C-reactive protein and procalcitonin. Data about overall morbidity, intraoperative complications, quality of postoperative recovery, red blood cell transfusion rate, all-cause infection rate, antibiotic usage, as well as length of hospital stay will be collected. The researchers will compare the group of patients with iron deficiency anaemia, the group of patients with iron deficiency in the latent stage and the control group to determine whether patients with iron deficiency have a higher incidence of perioperative complications and impaired recovery after surgery. The researchers will investigate whether iron deficiency can be detected at an early stage, when anaemia is not yet present, by calculating various red blood cell indices.
Title: Efficacy and safety of Avatrombopag VS Avatrombopag combined with rhTPO in patients with severe aplastic anemia: a single-center, controlled study Observation group: Patients with severe aplastic anemia who did not respond to initial treatment (unconditional HSCT or ATG) or other treatments (except HSCT) Objective: To evaluate the efficacy and safety of Avatrombopag and rhTPO in the treatment of patients with severe aplastic anemia, to provide more treatment options for patients with severe aplastic anemia who are unable to undergo transplantation /ATG or have failed previous treatment, and to provide evidence-based evidence for the use of Avatrombopag or combined with rhTPO to promote hematopoietic recovery Experimental design: Single center, controlled study Total number of cases: 30 cases/group, 2 groups Case selection criteria: Inclusion criteria: 1. Age: > 18 years old, gender is not limited; 2. Patients clinically diagnosed with severe aplastic anemia (diagnostic criteria: ① myelocyte hyperplasia < 25% of normal; If ≥ 25% of normal but < 50%, the remaining hematopoietic cells should be < 30%. ② Blood routine must have two of the following three items: ANC < 0.5×109 /L; The absolute value of reticulocyte was < 20×109 /L; PLT < 20×109 /L). ③ If ANC < 0.2×109 /L, the diagnosis is very severe aplastic anemia), including patients who are newly diagnosed or have failed other treatments; 3. Patients currently undergoing hematopoietic stem cell transplantation or ATG without conditions; 4. Eastern Cancer Collaboration Group (ECOG) score 0-2; 5. Informed consent must be signed before participating in the study. Exclusion criteria: One of the following circumstances is not eligible for inclusion: 1. Patients with severe bleeding and/or infection that cannot be controlled after standard treatment; 2. Diagnosis of congenital hematopoietic failure (such as Fanconi anemia, congenital dyskeratosis, etc.); 3. Other causes of pancytopenia and bone marrow hypoproliferative diseases (such as hemolytic PNH, hypoproliferative MDS/AML, autoantibody-mediated pancytopenia, etc.); 4. All laboratory or clinically confirmed HIV infection, hepatitis C infection, chronic hepatitis B infection, or evidence of active hepatitis during screening; 5. Cytogenetic evidence of bone marrow abnormalities in clonal blood diseases; 6. History of thromboembolism or current use of anticoagulants within the past 6 months; 7. Accompanied by any one or more malignant diseases; 8. Treatment with another investigational agent within 30 days prior to the first dose of Avatrombopag; 9. Patients who cannot understand or are unwilling to sign an informed consent form (ICF); 10. Pregnant or lactating women; 11. The female patient or the female spouse of the male patient is unable to take effective contraceptive measures; 12. The Investigator considers that there are any other circumstances that may cause the subject to be unable to complete the study or that pose a significant risk to the subject. Exit criteria: 1. The subject or his legal guardian voluntarily requests withdrawal; 2. Violation of inclusion/exclusion criteria; 3. Poor medication compliance; 4. The subject's condition requires treatment with drugs prohibited by the study; 5. Adverse events occur that cause subjects to be unable to continue the study; 6. Other unexplained severe comorbidities; 7. Pregnancy occurs during treatment; 8. Subjects deemed unsuitable for further study by the investigator. Test termination: 1. For safety reasons, the study sponsor proposes to stop the study; 2. The Ethics committee decides to stop the study; 3. The lead researcher decides to stop the study. Investigational drug: Avatrombopag: tablet, specification: 20 mg/ tablet. rhTPO: 15000 units /1 ml. Treatment plan: This clinical trial is planned to carry out a 3-month drug study. A: The Avatrombopag group was given Avatrombopag: 40 mg/ time, once a day, orally, for 3 months. B: Avatrombopag +rhTPO group, Avatrombopag: 40 mg/ time, once a day, orally; rhTPO: 15000U/ time, once a day, subcutaneous injection; Both were 3 months. Efficacy index: Main therapeutic indicators: Overall response rate at 3 months (OR); Secondary efficacy measures: Complete response rate at 3 months (CR); The time of the first occurrence of PR and CR within 3 months of medication; The proportion of subjects who were off platelet transfusion at 3 months; Hemorrhage score records of patients within 3 months of medication; Health-related quality of life score (SF-36 scale). Efficacy criteria: Complete response (CR) : HGB > 100 g/L; ANC > 1.5 × 109 /L; PLT > 100×109/L; Partial response (PR) : disengagement from component blood transfusion and no longer meeting the diagnostic criteria for SAA; Invalid (NR) : SAA diagnostic criteria are still met.