View clinical trials related to Venous Thromboembolism.
Filter by:This is an observational study in which only data will be collected from children with venous thromboembolism who are prescribed rivaroxaban or warfarin by their doctors. Venous thromboembolism (VTE) is a condition in which people have problems due to the formation of blood clots in their veins. The study drug rivaroxaban is an approved treatment for VTE in children and adults in Japan. It is a blood thinner that prevents the blood from clotting by blocking a protein responsible for blood clotting. Warfarin is another blood thinner that is available for VTE. In this study warfarin is the reference drug. A previous study was carried out to learn about how well rivaroxaban works and how safe it is in children with VTE. However, to better understand the safety of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding in children taking rivaroxaban. Major bleeding can be bleeding within the skull, bleeding inside the eye, bleeding from an organ in the digestive system, or bleeding which requires being given blood from a donor. In addition, this study will help learn more about the following in children with VTE: - The occurrence of major bleeding during treatment with rivaroxaban and during treatment with warfarin - The occurrence of bleeding of importance in children being treated with rivaroxaban and in children being treated with warfarin. Bleeding of importance in children can be: bleeding from the lung, blood in the kidney, heavy menstrual bleeding - The occurrence of major bleeding and bleeding of importance in children who are taking drugs called anti platelet agents and NSAIDs to prevent blood clots at the same time as rivaroxaban, who are taking a drug that blocks the action of a protein called 'CYP3A4' at the same time as rivaroxaban, who have reduced kidney function, who have taken rivaroxaban for a long time, or who have taken other drugs by mouth to prevent blood clots before starting rivaroxaban - The occurrence of repeated VTE on treatment with rivaroxaban and on treatment with warfarin The children with VTE in this study are already receiving rivaroxaban or warfarin treatment as part of their regular care from their doctors. The data will come from an electronic health records database created by a company called Medical Data Vision. The data will be collected between January 2021 and June 2024. Researchers will look at the health information from children less than 18 years of age with VTE in Japan who are prescribed treatment with rivaroxaban or warfarin during the study period. In this study, only available data from routine care are collected. No visits or tests are required as part of this study
The purpose of this study is to identify and validate new imaging biomarkers allowing an individual phenotyping of patient with venous thrombo-embolism (VTE), mainly in terms of recurrence risk assessment and to distinguish provoked from unprovoked VTE. To do so, the investigators will create a retrospective imaging database including multiple imaging modalities, performed at diagnosis of the VTE.
Venous thromboembolic disease (VTE) is a frequent and potentially serious pathology. Therapeutic management has improved considerably over the last few decades, enabling the application of codified management in line with the recently updated French management recommendations. One of the main remaining difficulties concerns VTE sequelae, mainly post-thrombotic syndrome after deep vein thrombosis, and post-pulmonary embolism syndrome after pulmonary embolism. The mechanisms leading to the absence of complete repermeabilization of vessels affected by Venous thromboembolic disease (VTE) are still poorly understood. The concept of immunothrombosis, closely associating immunity, inflammation and thrombosis, could (in part) explain the appearance of these sequelae. Platelets appear to play a key role in the onset of sequelae: Platelets are known to be involved both in the onset of a VTE episode and in the inflammatory response. This involvement is illustrated by the expression of inflammatory receptors such as TLR (toll-like receptor) 2 and TLR4. Th aim to investigate the role of platelets in the occurrence of sequelae, mainly via their role in the inflammatory response, in Venous thromboembolic disease (VTE) patients.
A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.
This study is designed to evaluate the efficacy and safety of SHR-2004 injection in preventing postoperative venous thromboembolism in patients undergoing ovarian cancer surgery.
This research will be carried out to determine the effectiveness of teaching thromboembolism risk assessment during pregnancy and postpartum period to midwifery students using a high-tech simulation method. Thromboembolism during pregnancy and postpartum period is one of the preventable causes of maternal deaths. For this reason, it is important to determine the thromboembolism risk of pregnant women and postpartum women by midwives before complications develop and to plan preventive interventions. The aim of the research is to provide midwifery students with the ability to evaluate the risk of thromboembolism before clinical experience through high-tech simulation application. Goals; - To increase midwifery students' skills in assessing thromboembolism risk during pregnancy and postpartum period before clinical practice. - To increase the self-confidence and satisfaction of midwifery students with simulation application in pregnancy and postpartum thromboembolism risk assessment skills. - To develop midwifery students' quick, critical thinking and decision-making skills in assessing the risk of thromboembolism before clinical practice. - To help midwifery students visualize the risk of pregnancy and postpartum thromboembolism, which has an important place in terms of maternal deaths, by creating a clinical environment with a case scenario. - To determine the effectiveness of midwifery teaching through case scenario simulation application with the risk of pregnancy and postpartum thromboembolism, and to increase students' learning and clinical practice skills.
Glioma is a common brain tumor with a high risk of venous thromboembolism during treatment, especially in the months after surgery. Postoperative lower extremity dyskinesia in patients with gliomas is considered as a high-risk factor for venous thromboembolism. Rivaroxaban, as an oral anticoagulants, has similar effect in the prevention and treatment of tumor-related venous thromboembolism compared to low molecular weight heparin. Given the lack of prospective supporting data, the efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in glioma patients with postoperative lower extremity dyskinesia need to be established.
Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.
There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.
This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure. Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding. A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients. To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.