Cold Agglutinin Syndrome

Researchers are evaluating the ABL90 FLEX PLUS HEM device for its ability to detect hemolysis in blood samples within a clinical setting. The study focuses on assessing the device's analytical performance, particularly the hemolysis detection feature, by comparing its results to established reference methods. This feasibility performance study aims to gather data that will support future clinical trials and regulatory approval processes. The study involves testing whole blood samples from adults admitted to the hospital, many of whom are critically ill and may be unconscious or sedated. Blood samples are collected as part of standard care, often through existing arterial or venous lines, without adding extra burden to the patient. The device's hemolysis detection function is being assessed during these routine blood collections at a single clinical site with trained personnel following a strict protocol. Participants will have their blood samples analyzed once per session to measure hemolysis levels, with outcomes including the percentage of samples correctly classified into hemolysis categories. Additional measurements include changes in hemoglobin concentration over time and correlations with established hemolysis indices and potassium levels. The study ensures informed consent from participants or their legal representatives and monitors safety by excluding those for whom sample collection poses unnecessary risk. The total study duration and participant involvement are aligned with routine hospital care procedures.

Researchers are studying the genetics behind non-malignant blood diseases to better understand their causes and how they affect people differently. This observational study collects and stores various biological samples and health information from individuals with these blood disorders and their family members. The aim is to explore genetic and genomic factors that might explain disease development, progression, and treatment responses, using advanced technologies such as next-generation sequencing and single-cell analysis. Participants include individuals diagnosed or suspected to have genetic blood disorders and their biologically related family members. Samples collected include blood, bone marrow, hair follicles, nail clippings, urine, saliva, buccal swabs, and leftover tissue. Medical histories and family pedigrees are reviewed with genetics experts, and participants may be contacted annually for updated information. Biological family members provide blood samples to support genetic testing and research. During the study, participants provide samples at enrollment and periodically over time, sometimes yearly or as needed until July 2050. Researchers will analyze genetic variations, modifier genes, and biomarkers linked to disease status and treatment outcomes. The study measures include the percentage of participants agreeing to participate and the types of genetic alterations found. Participants' health and genetic data will be reviewed long-term to improve understanding of blood diseases.

Researchers are studying blood management in children under 18 years old who undergo heart surgery with cardio-pulmonary bypass. The study aims to understand the best amounts and types of blood products to use during these surgeries and to develop a mathematical model that could help predict and treat patients needing blood transfusions in this setting. The study is observational and involves collecting discarded blood samples taken from routine clinical labs during and after heart surgery at Boston Children's Hospital. These samples will be used to assess intraoperative hemolysis, which is the breakdown of red blood cells, using plasma free hemoglobin measurements during cardio-pulmonary bypass. Additionally, the study will examine hemolysis in vitro by co-incubating salvaged red blood cells with patients' plasma compared to their baseline red blood cells. Participants will be monitored during their heart surgery and routine lab work, with researchers analyzing blood samples collected during and after surgery. The main outcome measured is the level of hemolysis during surgery. This study does not involve experimental treatments but focuses on careful observation and modeling, with the overall goal of improving blood transfusion management for pediatric heart surgery patients. The study is expected to run until the end of 2026.

Researchers are evaluating the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the risk of acute kidney injury following cardiac surgery. Pulsatile flow mimics the natural pulse of a beating heart, compared to non-pulsatile flow which provides a constant blood flow. The study aims to compare these two methods to see if pulsatile flow improves clinical outcomes after surgery, particularly kidney health. Participants will be randomly assigned to receive either pulsatile or non-pulsatile blood flow during their cardiopulmonary bypass procedure. Both methods are standard care approaches used to maintain blood circulation while the heart is stopped during surgery. Pulsatile flow is generated by varying the pump rate to create pulses, while non-pulsatile flow uses a constant pump rate. The study does not involve masking or blinding. During the study, participants will be monitored from the time they enter the intensive care unit after surgery for up to seven days to assess kidney injury and other outcomes. Researchers will track acute kidney injury, blood transfusions, platelet counts, and mortality up to 30 days after surgery. The study will also observe the use and discontinuation of bypass modes and monitor safety. The total participation timeline includes the surgery and follow-up assessments in the hospital.

Researchers are studying autoimmune cytopenias, including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune neutropenia, to better understand how these conditions are diagnosed and treated. The study also includes a subgroup of patients with myelodysplastic syndromes to investigate immune activation and red blood cell metabolism. The goal is to evaluate diagnostic tools, treatment types, responses, and predictors of outcomes over time. Participants will be observed without receiving experimental treatments. They will undergo clinical and laboratory evaluations such as immunohematology, cytokine assays, bone marrow studies, molecular tests, and fecal microbiome analysis. Patients will be sampled at diagnosis and followed for at least three years to track their clinical course, therapies used, response rates, relapses, and any complications like infections or thromboses. Throughout the study, participants will provide samples including peripheral blood and feces for detailed laboratory analyses. Researchers will assess the sensitivity and specificity of diagnostic tests and monitor various biological markers, including cytokine levels and somatic mutations. Data on treatment safety and effectiveness in routine practice will be collected, and participants will be regularly monitored for up to three years to understand the progression and outcomes of their conditions.

Restless leg syndrome is a common issue among people undergoing hemodialysis, but the effects of Buddhist walking meditation on this population have not been studied. This trial aims to evaluate whether Buddhist walking meditation can help improve symptoms of restless leg syndrome in hemodialysis patients. The study is interventional and will include 40 participants who experience this condition. Participants will be divided randomly into two groups of 20 each. One group will practice Buddhist walking meditation for 30 minutes three times a week, with 5 minutes of stretching exercises before and after each session, for a total of 12 weeks. The other group will serve as a control and will not receive any training or meditation. This design allows comparison of the meditation's potential effects against no intervention. Throughout the 12 weeks, researchers will measure symptoms using the International Restless Legs Syndrome Study Group Rating scale. Additional assessments include sleep quality, fatigue, physical and mental health, depression, anxiety, blood pressure, and various blood markers. These evaluations will be done before and after the study period to monitor changes and safety. Participants will attend regular sessions and assessments as part of their involvement.

Researchers are evaluating danicopan as an add-on treatment to ravulizumab or eculizumab in pediatric participants aged 12 to 17 years who have paroxysmal nocturnal hemoglobinuria (PNH) with clinically significant extravascular hemolysis (CS-EVH). The main goal is to assess the change in hemoglobin levels from the start of the study to Week 12, focusing on how adding danicopan affects this blood condition. Participants receive danicopan based on their weight during a 12-week open-label treatment period, followed by up to a one-year open-label long-term extension. The study does not include randomization or blinding, and all participants continue their stable dose of ravulizumab or eculizumab throughout the trial. During the study, researchers monitor hemoglobin changes, reticulocyte counts, plasma danicopan levels, quality of life, fatigue, and other blood markers at various points up to Week 64. Safety and tolerability are followed closely through laboratory tests and questionnaires. The total participation includes the initial 12-week treatment and the optional extended follow-up period.

This research focuses on adolescents with end stage renal disease (ESRD) who are undergoing regular hemodialysis and often experience problems such as poor ventilation, early fatigue, and reduced physical endurance. The study aims to evaluate how a walking program combined with the use of an incentive spirometer may improve these issues and enhance overall life quality. Forty adolescents with ESRD will be randomly divided into two groups. Both groups will use an incentive spirometer for 30 minutes during dialysis sessions, three times a week, over 12 weeks. One group will also participate in a walking program with a dog for 30 minutes, three times weekly on days without dialysis, to assess if this adds benefits. Participants will be assessed before and after the 12-week period using tests such as the six-minute walk test, lung function measurements like forced vital capacity and forced expiratory volume, maximal inspiratory pressure, and questionnaires on physical and mental health and fatigue symptoms. These measures will help evaluate physical tolerance, ventilatory function, fatigue, and quality of life during the study.

Researchers are enrolling patients with end stage renal disease (ESRD) who are receiving hemodialysis (HD) treatment to create a comprehensive HD database in China. This observational study aims to collect and compare patient survival, technical survival, access patency rates, quality of life, and residual kidney function among HD patients. The study is led by Sun Yat-sen University and includes patients treated at multiple hospitals. Participants have their demographic details, clinical characteristics, complications, medications, and quality of life measured at the start and then every 3 months during follow-up visits. Information recorded includes blood pressure, causes of ESRD, lab tests, and treatment outcomes such as mortality, kidney transplantation, access failure, hospitalizations, and transfer to other dialysis methods. During the study, patients are regularly assessed every three months with updates entered into the registration system. Researchers use this data to evaluate key outcomes like patient survival over 10 years, quality of life using the SF36 scale, and access patency rates. This ongoing follow-up helps provide detailed insights into the experiences and health of HD patients over time.