View clinical trials related to Venous Thrombosis.
Filter by:The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.
This study evaluates whether treatment with rosuvastatin on top of standard anti-coagulant treatment will decrease the risk of recurrent venous thromboembolism and arterial thromboembolic events in patients with previous deep vein thrombosis or pulmonary embolism.
Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment. Aim The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism. Hypothesis The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants. Design This is a multicenter, multinational, randomized, open label trial. Patients Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding. Sample size A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included. Organisation Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.
The issue to be studied is the prevalence of venous thromboembolism (VTE) in hospitalized pediatric patients, and to identify if there are subgroups of patients who may be at higher risk. There are two hypotheses that will be looked at in this study. The first hypothesis is that individual risk factors for VTE in hospitalized pediatric patients are: age >14, obesity, black race, female sex, presence of a central venous line (CVL), traumatic mechanism of injury, orthopaedic surgery, and use of oral contraceptives. The second hypothesis is that risk factors have an additive effect such that risk stratification can be developed to identify those patients with the highest risk.
The objective of this study is to investigate whether paracetamol, given at therapeutic doses (2g/day and 3 g/day), may potentiate the anticoagulant effect of warfarin.
This is a prospective, double blind controlled trial in which patients with esophagic variceal bleeding treated with standard therapy (endoscopic variceal ligation(EVL) + B-blockers), will be randomized to receive statins or placebo. They will be followed up during 12 months to determinate whether statins are effective in prevention of variceal bleeding recurrence and evaluate patient survival. Randomization will be stratified according to the degree of hepatic insufficiency, assessed by the Child-Pugh classifications (A,B or C).
The Registry involves the collection of information for research and educational purposes only on the use of AngioJet in the peripheral vascular system.
Arixtra (fondaparinux sodium) was the first selective Factor Xa inhibitor to be marketed. As with all anticoagulants, an important adverse event associated with Arixtra use is haemorrhage. Previous studies using clinical trial and observational data show no difference in the risk of haemorrhage in patients treated with Arixtra compared to (low molecular weight heparins) LMWHs. This study will assess the risk of haemorrhage in major orthopaedic surgery patients (hip fracture surgery and/or hip/knee replacement surgery) treated with either Arixtra or LMWH for thromboprophylaxis and will provide additional observational data from a European country to strengthen the comprehensive review of haemorrhage and the post-marketing safety of Arixtra. All patients age 18 years and older with a primary discharge diagnosis for hip fracture surgery and/or a hospitalization for hip and/or knee replacement surgery from the PHARMO RLS database in the Netherlands are eligible for participation. For study inclusion patients must receive either Arixtra or LMWH as initial in-hospital thromboprophylactic agent and have at least three months in the PHARMO RLS database before cohort entry date. Patients with a history of hospitalization for haemorrhage, renal failure or liver failure in the past 3 months will be excluded. Descriptive statistics, including gender, age, length of treatment, co-morbidities, concomitant medications, and other covariates will be calculated. Data for this study were obtained from different registers in the PHARMO medical record linkage system (PHARMO RLS) in the Netherlands. The PHARMO medical record linkage system is a population-based patient-centric data tracking system that includes high quality and complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million community-dwelling inhabitants of 48 geo-demographic areas in the Netherlands. The PHARMO registers are linked on a patient level and contain unprecedented accurate and complete information required for the study. The out patient database contains drug dispensing data in the U-Expo database are encoded according to standards based upon the Z-Index drug database (www.z-index.nl). Therefore, it is possible to identify and classify drug use in time, both on the basis of national and international classification schemes as well as on the basis of individual active ingredients and administration forms. Of each dispensed drug, the Anatomical Therapeutic Chemical (ATC) code, the dispensing date, the prescriber, the prescribed dosage regimen, the dispensed quantity, the cost and the estimated legend duration of use are available. The hospital pharmacy database comprises hospital pharmacy data collected in a growing number of non-academic hospitals in the Netherlands. Currently, data are collected on patient level for more than one million patients from a representative sample of non-academic hospital pharmacies scattered over the Netherlands. The hospital pharmacy database includes data on in-patient medication orders such as type of drug, dose, and time of administration and duration of use. The Dutch Medical Register (LMR) is the data source comprising all hospital admissions in the Netherlands (www.prismant.nl). These records include detailed information concerning the primary and secondary discharge diagnoses, diagnostic, surgical and treatment procedures, type and frequency of consultations with medical specialists and dates of hospital admission and discharge. All diagnoses are coded according to the International Classification of Diseases, 9th edition (ICD-9-CM). Currently, data until December 2008 are available.
Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty. A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property. We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.