393 Clinical Trials for Various Conditions
The current study investigates the effect of hypotensive anesthesia on patient hemoglobin levels during primary total knee arthroplasty. Considering that because of the tourniquet there is no blood loss during the first 60 minutes of the procedure changes in hemoglobin during the first 60 minutes should be primarily related to decrease in blood pressure and secondary to fluid loading during hypotensive anesthesia.
The purpose of this study is to evaluate the clinical utility of the StatStrip Lactate, Hemoglobin and Hematocrit Hospital Meter System in the testing of whole blood specimens from patients in hospital settings by CLIA waived operators, over a period of at least twenty days. The specimens shall include capillary (obtained by fingerstick), and venous whole blood. The study will also evaluate the use of a Fingerstick Blood Contamination Barrier for capillary sampling from the fingertip. This submission to the FDA is intended for a Point of Care (POC), CLIA waived device for whole blood capillary and venous lactate, and hemoglobin and hematocrit measurements.
This project is a prospective observational study aimed to assess the use of non-invasive hemoglobin measurement in anticipating postpartum hemorrhage and predicting estimated blood loss. The non-invasive hemoglobin device is the Radical-7 Pulse CO-Oximeter which is a spectrophotometer manufactured by Masimo, Inc. Participants in the study will be undergoing a cesarean delivery at the George Washington University Hospital and during delivery the patient will wear the device on their fingertip so that hemoglobin measurements can be continuously recorded. No changes from routine medical management will occur during the study.
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
The purpose of this multi-center study in non-dialysis participants with anemia associated with CKD is to evaluate safety, efficacy and quality of life of daprodustat compared to placebo.
This is a prospective cohort study of patients delivering at Columbia University Medical Center/ Allen Hospital. For the primary research question, the investigators will compare the change in maternal hemoglobin from postpartum day 1 to day 2 and also determine correlation with estimation of blood loss (EBL) and quantitative blood loss (QBL).
A non-invasive hemoglobin monitor will be used during cesarean delivery and the values obtained will be compared to values obtained from traditional blood draw.
The study is a clinical trial to determine whether more efficient medical and operational outcomes can be achieved with using the new SpHb monitoring during triage in the emergency room setting. The investigators also evaluate the accuracy of the measurements of the SpHb device by Maximo versus the gold standard of central hospital laboratory value. In addition, the investigators will assess patient satisfaction with the tool.
The purpose of the study is to determine whether noninvasive hemoglobin monitoring is sensitive and accurate enough to detect a significant downward trend in hemoglobin in patients at risk for significant bleeding. If this can be shown, it has the potential to spare patients multiple invasive blood draws as well as allow for earlier detection of significant blood loss and therefore positively impact on patient morbidity and mortality. Additionally, it may represent significant financial cost savings in that it may allow for patients to be monitored in a non-intensive care unit setting. This will be an observational study. The continuous hemoglobin monitor will be connected to the patient and hemoglobin measurement data will be collected. Routine laboratory hemoglobin monitoring will occur concurrently at a pre-specified frequency as well as at the physician's discretion based on usual clinical information. The physician will be blinded to the continuous hemoglobin monitoring readings and therefore patient care will not be affected by the use of the monitor. Once the study has ended, the data will then be analyzed to assess for correlation between continuous hemoglobin monitoring readings and laboratory hemoglobin measurement.
Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.
This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.
This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.
The purpose of this study is to determine the clinical utility of non-invasive monitoring of Hemoglobin (Hgb) and Plethysmograph Variability Index (PVI) values during the intraoperative period of visceral solid organ transplantation in children. Hemoglobin values reflect oxygen-carrying capacity of the blood and PVI reflects fluid balance and perfusion.
The purpose of this study is to determine whether the timing of the clamping of the umbilical cord after delivery has an impact on neonatal hemoglobin and hematocrit, tests that determine the number of red cells in the blood and their ability to carry oxygen. The study hypothesis is that delaying cord clamping until cord pulsation has ceased will increase the neonatal blood volume and thereby increase the hemoglobin and hematocrit. We propose to recruit 150 women who present for vaginal delivery at Tulsa Regional Medical Center. Half of the women will be randomly assigned to the immediate clamping group, which will entail clamping of the umbilical cord within six seconds of delivery of the fetal shoulders. The other half of the volunteers will be assigned to the delayed clamping group, which will entail clamping the cord after a palpable pulse has ceased, or after 10 minutes. The infants of mothers in both groups will have blood drawn for a hemoglobin and hematocrit at the time of the routine PKU heel stick, usually is performed within 18-24 hours of delivery. Statistical differences between the blood counts of infants in the control and study groups will be compared using independent samples t tests.
Our Practice Advisory (OPA) are essential tools in clinical decision-making. The alerts are designed to guide providers towards evidence-based practices and improve patient outcomes. The focus of this initiative is on Hemoglobin A1c (A1c) and Thyroid-Stimulating Hormone (TSH) testing, with the goal of addressing unnecessary repeat testing within a 30-day timeframe, which rarely yields significant new insights. Although randomization occurs at the patient level, the primary outcome of this study focuses on provider behavior and decision-making. By focusing on this specific intervention, the study aims to optimize resource use, align test ordering with evidence-based guidelines, and support improved patient outcomes. The results of this evaluation will help refine OPAs and guide broader strategies for implementing clinical decision support tools across healthcare systems.
A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.
This clinical trial evaluates the effects of hemoglobin threshold-specific packed red blood cell (PRBC) transfusions on quality of life and functional outcomes in patients who have undergone chemotherapy or an allogeneic hematopoietic stem cell transplant for a high-grade myeloid neoplasm, acute myeloid leukemia, or B acute lymphoblastic lymphoma/leukemia. Some types of chemotherapy and stem cell transplants can induce low platelet counts and/or anemia that requires PRBC transfusions. Given critical shortages in blood supply, and risks associated with transfusion of PRBC, there has been much investigation into the "minimum" hemoglobin level that effectively balances safety and toxicity in patients. This clinical trial evaluates the effects of giving PRBC transfusions based on a more restrictive hemoglobin threshold (\> 7 gm/dL) compared to a more liberal hemoglobin threshold (\> 9 gm/dL) on quality of life and functional outcomes. A more restrictive threshold may be just as effective at maintaining patient quality of life and function while decreasing side effects from blood transfusions and helping to conserve blood supply resources.
A promising approach for the treatment of genetic diseases is called gene therapy. Gene therapy is a relatively new field of medicine that uses genetic material (mostly DNA) from the patient to treat his or her own disease. In gene therapy, the investigators introduce new genetic material in order to fix or replace a diseased gene, with the goal of curing the disease. The procedure is similar to a bone marrow transplant, in that the patient's malfunctioning blood stem cells are reduced or eliminated using chemotherapy, but it is different because instead of using a different person's (donor) blood stem cells for the transplant, the patient's own blood stem cells are given back after the new genetic material has been introduced into those cells. This approach has the advantage of eliminating any risk of Graft-Versus-Host Disease (GVHD), reducing the risk of graft rejection, and may also allow less chemotherapy to be utilized for the conditioning portion of the transplant procedure. The method used to fix or replace a diseased gene is called gene editing. A person's own cells are edited using a specialized biological medicine that has been formulated for use in human beings. Fetal hemoglobin (HbF) is a healthy, non-sickling kind of hemoglobin. Investigators have recently discovered a gene called BCL11A that is very important in the control of fetal hemoglobin expression. Increasing the expression of this gene in sickle cell patients could increase the amount of fetal hemoglobin while simultaneously reducing the amount of sickle hemoglobin in their blood, and therefore potentially cure the condition.
This is a prospective, longitudinal, non-therapeutic study which includes routine assessment for long-term effects, as per FDA guidelines after receipt of an allogeneic HCT or autologous genetically modified cellular products for hemoglobin disorders. Primary objective: - To provide long term follow up, for individuals with hemoglobin disorders undergoing allogeneic hematopoietic stem cell transplantation (HCT) or receipt of an autologous genetically modified cellular product to treat their hemoglobinopathy. For individuals receiving a genetically modified cellular product, this long term follow up study is in accordance with the guidelines provided by the Food and Drug Administration (FDA).
Anemia is common during pregnancy due to increased metabolic rate and normal physiologic changes associated with pregnancy. Anemia during pregnancy has been associated with increased of adverse outcomes during delivery and the postpartum period. Currently, it is recommended to screen for anemia at three pre-specified points during routine prenatal care, typically 3 months apart. This screening method may miss patients who develop anemia between these intervals and lead to a delay in diagnosis and treatment. MasimoTM has developed a non-invasive device that can detect anemia without a blood draw. This device has not been extensively studied in pregnant patients. The aim of this study is to determine the agreement in hemoglobin readings between the non-invasive device and the standard of care blood draws in pregnant patients.
Background: Sickle cell disease (SCD) is an inherited disorder of the blood. SCD causes red blood cells (RBCs) to die early. This can lead to a shortage of healthy cells. SCD and other blood disorders can be managed with drugs or cured with a bone marrow transplant. Researchers want to know how long RBCs survive in people with SCD and other blood disorders before and after treatment compared to those who had a bone marrow transplant. Objective: To learn how long RBCs survive in the body in people with SCD and other blood disorders compared to those whose disease was cured with a bone marrow transplant. Eligibility: People aged 18 years or older with SCD or another inherited blood disorder. People whose SCD or blood disorder was cured with a bone marrow transplant are also needed. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Participants will have about 7 tablespoons of blood drawn. In the lab, this blood will be mixed with a vitamin called biotin. Biotin sticks to the outside of RBCs. This process is called "biotin labeling of RBCs." The next day, the participant s own biotin-labeled RBCs will be returned to their bloodstream. Participants will return regularly to have smaller blood samples (about 2 teaspoons) drawn. These samples will be tested to detect the percentage of cells that have biotin labels. These visits may be every 2 weeks, 4 weeks, or some other interval. Participants will continue this schedule for up to 20 weeks or until biotin can no longer be detected....
This study will investigate the role of genetic modifiers in hemoglobinopathies through a large-scale, multi-ethnic genome-wide association study (GWAS).
This study will utilize the Moxy wearable sensor to measure muscle oxygen saturation levels in athletes following lower extremity surgery (ACL or Hip arthroscopy) to evaluate their Return-to-Play. The acquired data will complement current protocols utilized by Dr. Voos and Dr. Salata in this regard and will add quantifiable evidence to enable a robust measurement of the surgical limb versus non-surgical limb.
This research is being done to better understand the accuracy of noninvasive hemoglobin tests on patients that recently underwent total joint arthroplasty.
This multi-center, prospective study will evaluate the use of topical tranexamic acid (TXA - Cyklokapron; Pfizer, New York, NY) on pre-operative and post-operative hemoglobin (Hb)/hematocrit (Hct) in patients undergoing operative repair of isolated posterior wall (PW) acetabular fractures.
A promising approach for the treatment of genetic diseases is called gene therapy. Gene therapy is a relatively new field of medicine in which genetic material (mostly DNA) in the patient is changed to treat his or her own disease. In gene therapy, we introduce new genetic material in order to fix or replace the patient's disease gene, with the goal of curing the disease. The procedure is similar to a bone marrow transplant, in that the patient's malfunctioning blood stem cells are reduced or eliminated using chemotherapy, but it is different because instead of using a different person's (donor) blood stem cells for the transplant, the patient's own blood stem cells are given back after the new genetic material has been introduced into those cells. This approach has the advantage of eliminating any risk of graft versus host disease (GVHD), reducing the risk of graft rejection, and may also allow less chemotherapy to be utilized for the conditioning portion of the transplant procedure. To introduce new genetic material into the patient's own blood stem cells we use a modified version of a virus (called a 'vector') that efficiently inserts the "correcting" genetic material into the cells. The vector is a specialized biological medicine that has been formulated for use in human beings. Fetal hemoglobin (HbF) is a healthy, non-sickling kind of hemoglobin. The investigators have discovered a gene that is very important in controlling the amount of HbF. Decreasing the expression of this gene in sickle cell patients could increase the amount of fetal hemoglobin while simultaneously reducing the amount of sickle hemoglobin in their blood, specifically the amount in red blood cells where sickle hemoglobin causes damage to the cell, and therefore potentially cure or significantly improve the condition. The gene we are targeting for change in this study that controls the level of fetal hemoglobin is called BCL11A. In summary, the advantages of a gene therapy approach include: 1) it can be used even if the patient does not have a matched donor available; 2) it may allow a reduction in the amount of chemotherapy required to prepare the patient for the transplant; and 3) it will avoid certain strong medicines often required to prevent and treat GVHD and rejection. Our lab studies with normal mice, mice that have a form of SCD, and with cells from the bone marrow of SCD patients who have donated bone marrow for research purposes show this approach is very effective in reducing the amount of sickle hemoglobin in red cells. Our pilot trial testing this approach in 10 patients with SCD has shown that the treatment has not caused any unexpected safety problems, and that it increases HbF within the red blood cells. Our goal is to continue to test whether this approach is safe, and whether using gene therapy to change the expression of BCL11A will lead to decreased episodes of vaso-occlusive crisis pain in people with SCD.
This study will examine the effects of regular almond consumption by individuals with elevated HbA1c on long-term glycemic control.
This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)
The primary objective of the study is: To evaluate the effect of pozelimab and cemdisiran combination therapy on hemolysis, as assessed by lactate dehydrogenase (LDH), after 36 weeks of treatment, in patients with PNH who switch from eculizumab or ravulizumab therapy versus patients who continue their eculizumab or ravulizumab therapy The secondary objectives of the study are to: * Evaluate the effect of pozelimab and cemdisiran combination treatment versus anti-C5 standard-of-care treatment (eculizumab or ravulizumab) on the following: * Transfusion requirements and transfusion parameters * Measures of hemolysis: LDH control, breakthrough hemolysis, and inhibition of CH50 * Hemoglobin levels * Fatigue as assessed by Clinical Outcome Assessments (COAs) * Health-related quality of life (HRQoL) as assessed by COAs * Safety and tolerability * To assess the concentrations of total pozelimab and either total eculizumab or total ravulizumab in serum and total cemdisiran and total C5 protein in plasma * To assess the immunogenicity of pozelimab and cemdisiran
The purpose of this study is to evaluate the safety, effectiveness, and biological activity (how the investigational medication is processed by the body) of pegcetacoplan in 12-17 year-olds (adolescents) who have paroxysmal nocturnal hemoglobinuria (PNH).