View clinical trials related to Thromboembolism.
Filter by:Patients with unprovoked venous thromboembolism (VTE) or VTE associated with persistent risk factors have a high risk of recurrence after stopping anticoagulation. In these patients, international guidelines recommend indefinite anticoagulation. However, prolonged use of warfarin or DOAC at therapeutic dose is associated with a significant risk of bleeding. Consequently, it has been hypothesized that extended anticoagulation at lower dosage might be as effective as and safer than full dose of anticoagulation. However, low-dose warfarin (INR 1.5-2) was less effective and not safer than conventional dose warfarin (INR 2-3). Low dose of DOAC has the potential to validate this hypothesis. In a first randomized trial comparing full-dose or low-dose apixaban with a placebo during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Amplify-extension trial"), low-dose apixaban was more effective than placebo without any major concern regarding safety and possibly as effective as and safer than full-dose apixaban; in a second randomized trial comparing full-dose or low-dose rivaroxaban with aspirin, during an additional one year of anticoagulation in patients where physicians were uncertain for prolonging anticoagulation ("Einstein-Choice trial"), low-dose rivaroxaban was more effective than aspirin without any major concern regarding safety and possibly as effective as and safer than full-dose rivaroxaban. However, these two studies were not designed and powered to demonstrate non-inferiority on efficacy and superiority on safety of a reduced dose of DOAC versus a full dose DOAC and the selected population did not have strong indications for indefinite anticoagulation. Thus, there is currently no evidence to recommend a reduced dose rather than a full dose of DOAC for extended therapy in patients at high risk of recurrent VTE. Consequently, a randomized trial comparing low-dose DOAC with full-dose DOAC therapy in patients at high risk of recurrent VTE is needed and justified. Main hypothesis: After VTE at high risk of recurrence initially treated during 6 (-15 days) to 24 (+ 3 months) uninterrupted months, a reduced dose of DOAC will be non-inferior to a full dose of DOAC in terms of recurrent VTE during extended anticoagulation phase.
Venous thromboembolism occurs with an incidence of about 1 per 1000 per year in adults . The main consequences are death, recurrence, post-thrombotic syndrome and major bleeding due to anticoagulation. Mortality rates are lower among patients with idiopathic venous thrombosis and higher among those in whom thrombosis occurs in the presence of cancer. The risk increases with the age for unclear reasons. There are also differences in the incidence according to ethnicity; however, data in subjects of European ancestry are scarce. Several studies have documented an association between thrombosis and ABO group. Specifically, non-O blood groups have a higher risk of myocardial infarction, angina, peripheral vascular disease, cerebral ischemia and venous thromboembolism than O. While there are numerous studies carried out in patients who have already shown thromboembolic events, data on the incidence of risk factors in the healthy population are completely inadequate. Understanding the risk factors for venous thrombosis is necessary to maximize the prevention of this disease in individuals and groups of high-risk patients . For this purpose a self-administered questionnaire will be used. Data obtained by blood donors on exposure to risk factors will be used to set up a clinical score to validate in future studies to carry out in patients with VTE.
This study was to compare the study drug BAY1213790 to existing therapies, i.e. enoxaparin or apixaban, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA). The study was open-label, but observer-blinded for the different doses of BAY1213790. This means that it was known which treatment was given, but it was not known which dose of BAY1213790 was administered.
The aim of this research is to better understand how patient-level factors can be used to predict the appropriate enoxaparin dose to maximize venous thromboembolism (VTE) risk reduction and minimize bleeding.
The purpose of this study is to explore the impact of using a smartphone app reminder on medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. This study will randomly assign participants to get usual postoperative care which is teaching with verbal instructions and printed information about taking the aspirin at the time of discharge, or to have an app on your smartphone with preset reminders in addition to usual postoperative discharge teaching after surgery.
Venous thromboembolism (VTE) is a serious source of hospital morbidity and mortality. Chemoprophylaxis with heparin has been shown to reduce the occurrence of VTE, but it increases the risk of bleeding and it is uncomfortable to receive. For that reason, VTE prophylaxis should be reserved for patients at moderate to high risk of VTE and low risk of bleeding. However, identifying patients at low risk for VTE can be difficult, because most patients have at least one risk factor for VTE and there are no validated risk prediction tools for use in US hospitals. Instead, many hospitals have opted for a one-size-fits-all approach with near-universal prophylaxis, putting many patients at unnecessary risk of bleeding. However, to provide care that is truly patient-centered, US physicians face several challenges. First, there is no accepted risk calculator that they can use to estimate an individual patient's risk. Second, risk calculators are not readily available at the point of care. As a result, prophylaxis rates have remained stubbornly low in some institutions, while in others the rate of prophylaxis is high, but the rate of inappropriate prophylaxis is also high. This study uses a risk prediction tool developed at the Cleveland Clinic to assess an individual patient's risk of VTE. The tool is incorporated into the electronic health record in the form of a smart order set. In this randomized trial, we will assess the effects of the order set on physician behavior and patient outcomes . Examining the effectiveness of an electronic decision aid embedded in an EHR in routine clinical practice will test whether a smart order set can improve patient care by incorporating patient-specific factors into a complex decision process.
To estimate the real-world rates of recurrent Venous thromboembolism (VTE), major bleeding and all-cause mortality in patients with Cancer-associated thrombosis (CAT) treated with rivaroxaban
Plastic and reconstructive surgeons consistently create large, raw surfaces as part of their operative procedures. Thus, plastic & reconstructive surgery patients are among those at highest risk for anticoagulant-associated bleeding adverse drug events (ADEs). This study seeks to optimize both the safety and effectiveness of post-operative enoxaparin by comparing aFXa levels, bleeding events, and VTE events among plastic & reconstructive surgery patients randomized to receive two different enoxaparin dose regimens.
Deep vein thrombosis (DVT) occurs when a blood clot forms in a deep vein, typically in the lower extremities. Pulmonary embolism (PE) occurs when a DVT clot (or fragment) breaks free and travels through the heart to the pulmonary arteries (having to do with the lungs) and lodges in an artery causing a partial or complete blockage. PE is difficult to diagnose due to the non-specific signs and symptoms patients have with this condition such as a cough, shortness of breath, increased heart rate, blood tinged sputum, low oxygen levels. The standard test to diagnose PE is the Pulmonary Computed Tomography Angiogram (CTA). This can be prohibitive with some patients due to the amount of radiation exposure as well as the complications associated with the need to use intravenous (IV) contrast. In this study the investigators are looking at an alternative method of diagnosing PE's in the Emergency Department where the investigators look at the breathing and blood flow to the lungs thru respiratory gated non-contrast CT (commonly called 4DCT). The investigators hypothesize that respiratory induced blood mass change in the lungs will allow the identification of under-perfused lung regions. Cohort 1: An anticipated15 participants will be enrolled with a diagnosis of PE by CTA. Each will receive SPECT/CT and 4DCT imaging on the same day. Respiratory induced blood mass change images will be issued from the 4DCT and compared to the SPECT/CT images. Cohort 2: An anticipated 5 participants will be enrolled under the same criteria and study procedures as Cohort 1. The participants in Cohort 2 will have the addition of Bilevel Positive Airway Pressure (BiPAP) during the 4DCT imaging. This cohort will be used to compare the effect of airway pressure on 4DCT image. Cohort 3: An anticipated 124 participants will be enrolled. Study procedure will be 4DCT only. Participants must be having or have had a CTA to rule in/out PE. This cohort of the study will be using 4DCT to compare negative CTA to positive CTA findings.
This is a clinical trial including non-surgical patients, 70 years of age or older, with renal impairment requiring pharmacological venous thromboembolism prevention during hospitalization. Patients are randomized to receive either 20 mg or 30mg of enoxaparin. Both dosing regimens of enoxaparin have been approved for thromboprophylaxis in impaired kidney function in different countries. Therefore, this study aims to evaluate the efficacy and safety of enoxaparin 20mg versus 30mg subcutaneously daily by comparing anti-xa levels, thrombosis and bleeding events.