Safety and Efficacy Study of Fitaya Vena Cava Filter
Venous ThromboembolismA Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis.
Enoxaparin Versus Placebo for Venous Thromboembolism Prevention in Low Risk Cancer Patients After...
Venous ThromboembolismBleeding as Surgical Complication (Treatment)2 morePost-surgical bleeding is a major source of morbidity in cancer patients, and ramifications can include need for transfusion, increased length of hospital stay, unexpected return to the operating room, or even death. Current guidelines support that all cancer patients who require surgical procedures receive post-operative blood thinners to minimize risk for blood clots in the legs or lungs, known as venous thromboembolism (VTE), but these medications have an unfavorable risk/benefit relationship among patients at low risk for VTE. The proposed work will pilot a randomized, double blind, placebo controlled trial to critically examine the role of de-implementation of current guidelines that mandate blood thinning medications among cancer patients at low risk for VTE who require surgical procedures; the pilot trial will allow optimization of the design of a future pragmatic multicenter trial, which ultimately would maximize patient safety after surgical procedures for cancer.
Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism...
Pulmonary EmbolismExercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.
Mortality Due to Malignancy in Patients With Idiopathic Venous Thromboembolism
Venous ThromboembolismMalignancyBackground Patients with an idiopathic venous thromboembolism (IVTE) appear to have a risk of approximately 10% for symptomatic malignancy within 3 years after the IVTE. It is not clear if extensive screening for malignant disease leads to survival benefit in patients with an IVTE. The SOMIT study learned that it is feasible to screen patients with an IVTE for malignancy and screening by means of a computer tomography (CT) of the chest and abdomen plus a mammography in women had the potential to be most cost-effective. The SOMIT study could not show a survival benefit due to the design of the study. Primary objective: cancer related mortality Methods: The Trousseau study has been designed as a multicenter, prospective concurrently controlled cohort study. Inclusion criteria: Proven first symptomatic deep venous thromboembolic event; Without: known risk factor for venous thromboembolism. Exclusion criteria: Proven deep venous thromboembolic event in the medical history, age under 40 years; Patients without signs of malignancy after routine investigations (medical history, physical examination, laboratory investigations and chest X-ray) were included. Depending on the standard care in the hospital of interest, one group of patients has been screened by means of CT-chest and abdomen plus mammography, the other group had no additional investigations. Follow-up was aimed to be 3 years in both groups (at 3, 6, 12, 24 and 36 months after the thromboembolic event). Data like mortality rate, morbidity due to screening procedures, additional investigations, number of cancer patients detected by the extensive screening, number of cancer patients three years after the IVTE, number and kind of investigations performed and information about cancer treatment and hospitalization was collected. If this information indicate a survival benefit these data enable us to perform a cost-effectiveness analysis. Endpoint: Mortality. Statistics: Based on the prevalence of occult malignancy in VTE patients, the nature and stage of malignancies, the expected mortality, the anticipated detection of cancers and the early treatment related decrease in mortality we needed, in order to detect a true difference of this size with a 80 percent power and a two-tailed certainty of five percent, 750 patients for each group. Therefore, a total of 1500 patients is required for this study.
Pradaxa (Dabigatran Etexilate) VTE Prevention After Elective Total Hip or Knee Replacement Surgery...
Venous ThromboembolismArthroplasty1 morean open, prospective, observational study to collect data on safety (major bleeding events) and efficacy (symptomatic venous thromboembolism(VTE)) of a switch from Enoxaparin to dabigatran etexilate in patients with total knee replacement (TKR) and total hip replacement (THR)
Prophylaxis of Venous Thrombo-Embolism in Cancer Patients Under Palliative Care
CancerVenous ThromboembolismTo determine the efficacy and to measure the complications of prophylactic anticoagulation using low-molecular weight heparin in adult cancer patients under palliative care
Aspirin for the Prevention of Recurrent Venous Thromboembolism
Venous ThromboembolismDeep Venous Thrombosis2 moreTo determine whether aspirin is more effective than placebo for the prevention of recurrent symptomatic venous thromboembolism when given for at least two years after the initial 6-12 month of oral anticoagulant therapy in patients with idiopathic venous thromboembolism
Multiple-Dose Study Apixaban in Pediatric Subjects With an Indwelling Central Venous Catheter
Venous ThromboembolismCV185-079 is a multiple dose Apixaban Pharmacokinetics/Pharmacodynamics (PK/PD) study in pediatric subjects. The objective of this study is primarily to study the PK/PD of Apixaban in pediatric subjects with a central venous catheter.
A Randomized Phase II Open Label Study to Compare the Safety and Efficacy of Subcutaneous Dalteparin...
Cancer-associated ThrombosisEsophageal Cancer9 moreThis is an open label, multi-center, and randomized phase II trial designed to compare the safety and efficacy of direct oral anticoagulants and subcutaneous dalteparin in patients with acute venous thromboembolism and upper gastrointestinal, hepatobiliary, or pancreatic cancer, based on a group sequential design. Enrolled patients will be randomized in a 1:1 ratio. Patients will be stratified by performance status, type of cancer, chemotherapy and medical centers.
The Association of Warfarin Dosage and Plasma Enantiomer Concentration With the Gene Polymorphisms...
Deep Venous ThromboembolismOral warfarin anticogulation for the prevention and treatment of patients with venous thromboembolism is one of the most used therapies in clinical practice. Patients require different dosage to achieve the target therapeutic anticoagulation. Optimal dosage and bleeding complication are two most clinical concerns. Besides of multiple individual factors (e.g. age, dietary intake, vitamin supplement, drug compliance etc.), some genetic factors may determine the drug requirement and safety. The cytochrome P450 CYP2C9 is a liver enzyme required for the oxidative metabolism of warfarin. The vitamin K epoxide redutase (VKOR) is a liver enzyme associated with the reuse of the oxidative hydroquinone form of vitamin K. The VKOR enzyme is the target of warfarin. Recent studies revealed both genes may determine the pharmacodynamic of warfarin anticogualation. To date, there are more than thirteen identified polymorphism at CYP2C9 gene. Majority of those variant polymorphisms may decrease the warfarin requirement. The VKOR complex subunit 1 (VKORC1) is a newly identified gene. Some polymorphisms also were reported. As we know, the Chinese patients need a lower dosage of warfarin in comparison with the Caucasian patients. We are interested in finding the genetic causes of Taiwneses Chinese patients. In our study we will first identify the polymorphism patterns of these two genes in normal population. Then, we will try to find the association between these polymorphism and patient warfarin requirement. Our pharmacogenetics study will be valuable for prevention of bleeding complication of warfarin treatment in Chinese population.