View clinical trials related to Venous Thromboembolism.
Filter by:This is a phase 4 cohort prospective, open, national, multicentre study that collects data on history of patients treated chronically with anticoagulant drugs, including the novel direct oral anticoagulants (DOACs). The Registry is designed solely for observational purposes and is not intended to have any influence on the treatment of the single patients included. Patients are included when they start the anticoagulant treatment, whatever the drug used, or when they shift from a vitamin K antagonist (VKA) drug to one of the novel direct oral anticoagulants, provided that the therapy is expected to last at least 3 months. The general aims of the study are to provide a better evaluation of efficacy and safety of different treatment options, and to improve our understanding of the risks/benefits of the various anticoagulant drugs and the different therapy options. The Registry is open to the participation of clinical centres or individual professionals (now called Participants) that are involved with management of anticoagulated patients.
The purpose of this study is to analyze the effect of the prophylaxis of venous thromboembolism in the critical ill patients, and at the same time, to find out the risk of venous thromboembolism and hemorrhage events occurred under the prophylaxis.
Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute venous thoromboembolism (VTE). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute VTE in routine clinical practice.
This research study is a prospective randomized trial evaluating the relative safety of two inferior vena cava (IVC) filters used to prevent the migration of potentially dangerous deadly blood clots from the legs to the lung in patients who cannot take blood thinners. All eligible patients will have been ordered to have a IVC filter placed by their primary medical team and filters will be placed in these patients whether or not they wish to participate in this trial as part of standard of care. The investigators will follow up with patients 30 days after IVC filter placement and ask them to come back for filter removal if medically appropriate. If removal is not medically appropriate in 30 days, the investigators will attempt to schedule removal every 30 days after initial placement. Primary outcome measures will be IVC filter complications such as filter penetration through the IVC wall and into other organs, filter tilt, filter migration, filter fracture and clots formed within the filter. All of these are reported complications of all IVC filters. The research also aims to improve the standard of care for IVC filter patient follow up as the FDA and Society of Interventional Radiology recommend that IVC filters be removed as soon as it is safe to do so. Hypothesis: The investigators hypothesize that there is no significant difference in efficacy and complication rate between the Option and the Denali filter.
This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.
The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).
The arrival on the market of direct oral factor Xa and factor IIa inhibitors (dabigatran (Pradaxa®), rivaroxaban (Xarelto®), apixaban (Eliquis®) and others soon to come) raises novel questions among clinicians confronted with the emergency management of patients treated with these new drugs. It is likely that these new oral anticoagulants (NOACs) will eventually win a significant market share in the indications secondary prevention of venous thromboembolism and prevention of cardioembolic events in patients with nonvalvular atrial fibrillation, due to their net clinical benefit and their practicality of use compared with vitamin K antagonists (VKAs). However, despite the fact that NOACs reduce the incidence of intracranial bleeding by about half compared with VKAs, the risk remains significant; furthermore, in clinical trials, these drugs had little or no effect on reducing the incidence of major extracranial bleeding. In everyday practice, where the indication could be expanded to unselected populations and due to a potential for misuse, it is likely that the incidence of bleeding complications will be higher than that reported in clinical trials. Indeed, the numerous alerts emanating from regulatory agencies in various countries (US, Australia, etc.) bear witness to this, and should serve as a reminder that these anticoagulants have a real potential for bleeding complications and, in the absence of an antidote, there is no validated management strategy. Furthermore, as these drugs can be prescribed for months or years, patients may eventually be exposed to situations at high hemorrhagic risk, such as emergency surgery or invasive procedures, trauma, etc. Analysis of data from the trial : dabigatran versus warfarin in patients with atrial fibrillation (RE-LY) showed that during the two years of follow-up, approximately 25% of the patients underwent an invasive procedure, ranging from pacemaker insertion to major surgery. Thus, a large proportion of patients treated with NOACs are concerned by this issue. In anticipation of a gradually increasing influx of patients in a critical situation (active bleeding or need to rapidly secure hemostasis before an invasive procedure), it is urgent to define the conduct to adopt based on the experience gained from the earliest cases. This is the objective of the French-speaking GIHP-NACO observatory set up by the GIHP (French Working Group on Perioperative Hemostasis). For the moment, then, the management recommendations derive from expert opinions based on pharmacokinetic data and on the partial correction of NOAC-induced hypocoagulability by various nonspecific procoagulants (non-activated or activated prothrombin complex concentrates, recombinant factor VIIa). These procoagulants are currently used in an empirical manner to control bleeding, with as many successes as failures reported in the literature, and their benefit-risk ratio in these patients is therefore uncertain.
To determine the PK profile of a single dose 150 mg BIBR 1048, oral capsule, administered 1-3 hours post surgery in hip replacement patients.
- To determine the therapeutic window of BIBR 1048 in order to select doses for further studies in the development plan. - Twice daily regimen will be tested for most dose levels and once daily administration will also be evaluated when appropriate.
Since 2003, that the first retrievable IVC filter was introduced in the U.S,improvements have been made in the filter design to resolve problems of structural integrity and increase the ability to remove the filter after longer periods of time.The FDA issued a communication in August 2010 advising physicians to remove retrievable filters whenever possible and updated that letter again in May 2014 due to concerns that these retrievable IVC filters, intended for short-term placement, are not always removed once a patient's risk for PE subsides. Known long term risks associated with IVC filters include but are not limited to lower limb deep vein thrombosis (DVT), filter fracture, filter migration, filter embolization and IVC perforation.