A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With...
Venous ThromboembolismChildren Under 2 YearsThis is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE). VTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening. Rivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information. The purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old. The main information that researchers will collect in this study: Age, gender, and other information about the child and their illness Type of VTE treatment given to the child Occurrence of medically important bleeding and its severity Further information that researchers will collect: Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE Return of VTE symptoms Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study. The data for this study will be collected from electronic health records and health insurance claims data until 2026. Researchers will observe each child during treatment until: end of the anticoagulation treatment period e.g. discontinuation of all study drugs, their information is no longer available, or the study ends.
Anti-factor Xa Based Venous Thromboembolism Prophylaxis
Dose Adjustment of Enoxaparin in ICU PatientsIntroduction: Venous thromboembolism (VTE) in the intensive care unit (ICU) is associated with significant morbidity and mortality therefore prevention is imperative to reduce its burden. VTE prophylaxis in ICU patients is primarily pharmacological using low molecular weight heparin. This study aims to determine the proportion of ICU patients receiving VTE prophylaxis that achieves appropriate anti-factor Xa activity (aFXa) prophylactic levels and to characterize this patient population Methods: Seventy-five patients admitted to the General ICU were included. Peak and trough aFXa levels were measured at 4 and 23 hours respectively after receiving the second consecutive daily enoxaparin 40 mg sc injection. Patients in whom peak aFXa levels were found to be sub-prophylactic, peak and trough levels were repeated as above
Comparison of Bleeding Risk Between Rivaroxaban and Apixaban
Venous ThromboembolismThis vanguard pilot study compares rivaroxaban and apixaban, two of the new oral blood thinners for the treatment of blood clots. Half of the patients will receive apixaban and half will receive rivaroxaban. The main objective is to determine the feasibility of patient recruitment and resources required to follow enrolled patients and inform for a larger, multi-centered trial and to assess which one is safer.
Cancer Associated Thrombosis, a Pilot Treatment Study Using Rivaroxaban
NeoplasmVenous ThromboembolismThe study will compare the efficacy and safety of oral rivaroxaban and subcutaneous dalteparin in patients with cancer associated thrombosis. It is designed as a non-inferiority open label randomized multicenter trial with blinded adjudication of outcome events.
Bemiparin Versus Enoxaparin in the Prevention of Venous Thromboembolism Among ICU Patients
Venous ThromboembolismThe purpose of this study is to compare two types of low-molecular-weight heparin, enoxaparin and bemiparin, as regards their efficacy and safety in venous thromboembolism prevention among intensive care unit patients.
RAMBLE - Rivaroxaban vs. Apixaban for Heavy Menstrual Bleeding
Venous ThromboembolismMenstruationA large proportion of women with menstruating potential with newly diagnosed VTE or atrial fibrillation, treated with apixaban will have less menstrual blood loss than patients randomized to rivaroxaban.
Apixaban for Extended Anticoagulation (APIDULCIS)
Venous ThromboembolismAnticoagulantsThe study aims at optimizing the long-term and extended management of patients with a first episode of venous thromboembolism (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients at high risk of recurrence (with altered D-dimer test), who had received anticoagulation (whatever the drug used) for 12-15 months after the first episode of thrombosis, will be treated with Apixaban 2,5 mg x 2 for 18 months as extended treatment. Patients at low risk, with normal D-dimer test, will stop anticoagulation definitely.
Clinical Trial of Dimolegin (DD217) in Prevention of Thrombotic Complications in Patients With COVID-19...
COVID-19Venous ThromboembolismStudy purpose was to study the safety and efficacy of Dimolegin - DD217 as a drug for prevention of thrombotic complications compared to Clexane (enoxaparin sodium) - the standard therapy currently prescribed to patients hospitalized with COVID-19. Patients who met all inclusion criteria and no exclusion criteria were randomized into two therapy groups: Group 1 - test drug Dimolegin - DD217 (60 mg orally, 1 time per day); Group 2 - reference drug Clexane (40 mg subcutaneously, 1 time per day). The study drugs were taken once a day until: the discharge from the hospital due to recovery or positive dynamics; or up to 30 days of the patient's stay in the hospital; or until the Investigator decides to discontinue the therapy for other reasons. Planned: screening of up to 450 patients, randomization: 430 (215 per group). The required number of patients is 200 per group as a result of the entire study.
Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia...
Medical PatientThrombocytopeniaFondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.
Follow on Study From RE-ALIGN
ThromboembolismHeart Valve ProsthesisTo collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.