View clinical trials related to Thromboembolism.
Filter by:The purpose of this study is to evaluate the effect of lidocaine, delivered into subcutaneous tissue for tumescent local anesthesia, on platelet activation following the tumescent liposuction.
Hepatitis C Virus (HCV) is a leading cause of chronic liver disease (CLD) worldwide. Current mainstay of treatment is combination therapy with pegylated interferon and ribavarin. Thrombocytopenia as a treatment related adverse event or a complication of chronic liver disease often necessitates dose reduction and discontinuation in these patients. Revolade®/Promacta® (eltrombopag) is an oral second generation thrombopoietic growth factor in development for the treatment thrombocytopenia associated with various conditions, including secondary thrombocytopenia related to CLD and hepatitis C. In 2009 a phase III trial for CLD patients undergoing an elective invasive procedure (ELEVATE) was terminated early due to an imbalance of thromboembolic events (TEE) between the placebo and the eltrombopag arm. Currently, two global interventional Phase III trials (ENABLE 1 and ENABLE 2) are being conducted in approximately 1500 patients to evaluate the efficacy of eltrombopag in enabling HCV patients to achieve sustained viral response. Due to the similarities between the patient groups in ELEVATE and ENABLE, there is a concern that invasive procedures may influence the risk of TEE in the ENABLE population. This observational, non-interventional, retrospective, multicentre, nested case-control study will collect data from chart abstraction and medical record review to augment data from the ENABLE case report forms particularly with regards to invasive procedures. The study population includes cases and controls drawn from the ~1500 participants of the ENABLE trials. All eligible cases of TEE will be included in the study as cases. All other patients who participated in the ENABLE trials and did not experience a TEE, will be eligible to be selected as controls. Case report forms will be developed to enable standardized data capture. The Sponsor has contracted with the Clinical Research Organization, Outcome Sciences Inc to manage the study. ENABLE investigators will work with Outcome staff to obtain relevant information from the treating physician (e.g. surgeon) and the facility where the invasive procedure was performed (pre-operative tests, peri-operative course, diagnostic testing for TEE). Single point abstraction will be performed to obtain data from the medical record and from any additional data resources obtained by the investigator (e.g., operative note, anesthesia record). Analyses will be conducted using logistic regression models to estimate the risks. The primary objective of the study is to evaluate if there is an increased risk for TEE among patients who had an invasive procedure while exposed to eltrombopag (during the ENABLE trials).
The optimal medical strategy for prevention of thromboembolic events after bioprosthetic aorta valve replacement (BAVR) remains controversial. The aim of this trial was to compare warfarin therapy (target INR of 2.0 to 3.0) against aspirin 150mg daily as antithrombotic therapy for the first three months after BAVR with or without concomitant coronary artery bypass grafting (CABG). The aim was to evaluate thromboembolic complications, bleeding complications and death.
This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.
A systematic review and meta analysis will be performed of risk assessment models for Venous thromboembolism ("VTE" including pulmonary embolism "PE" and deep venous thrombosis "DVT")in hospitalized medical patients. The goal of this study is to evaluate whether the incidence of VTE is lower in patients that are evaluated with a risk assessment model and treated with thromboprophylaxis for their assigned level of risk.
Rationale: After total knee arthroplasty (TKA) surgery, patients are at risk to develop venous thromboembolism (VTE) or deep venous thrombosis (DVT) potentially resulting in a fatal pulmonary embolism (PE). Two novel agents, dabigatran and rivaroxaban, recently gained market authorisation for prevention of venous thromboembolism after knee arthroplasty. However, there are no clinical trials with dabigatran and/or rivaroxaban and the comparator nadroparin. Nadroparin is used in the most Dutch departments of orthopaedic surgery after total knee arthroplasty. Also safety of the new oral agents with long term use of 42 days is not available for total knee arthroplasty. Our aim is to compare the long term use of dabigatran and rivaroxaban versus nadroparin on safety after total knee arthroplasty (TKA) in a clinical explorative pilot study by observing the incidence of major bleeding and clinical relevant non-major bleeding using a standardized model of bleeding definitions. Objective: The primary objective of this study is to compare the clinical safety with long term use of the oral once daily unmonitored thrombin inhibitors dabigatran and rivaroxaban versus subcutaneous administered nadroparin by observing the incidence of major bleeding and clinical relevant non-major bleeding in patients after knee arthroplasty surgery. The secondary objectives of this study are effectivity of the agents, compliance, hospital stay, re-hospitalisation, outpatient clinic visits and interventions following complications. Additionally, coagulation monitoring, knee flexion range of motion, Knee injury and Osteoarthritis Outcome Score (KOOS), Knee Society Score (KSS) and relationship between health statuses and surgery parameters will be evaluated. Study design: The study is designed as non-inferiority randomized open label controlled pilot study. A total of 150 patients will be included, 50 patients in each treatment group (dabigatran, rivaroxaban and nadroparin). Study population: Patients ≥ 18 years and weighing more than 40 kg, participate in the 'joint care program' for primary elective total knee arthroplasty and want to provide signed informed consent are eligible for the study. Intervention: Patients receive subcutaneously nadroparin or oral rivaroxaban or oral dabigatran after knee replacement surgery. Main study parameters/endpoints: The primary safety outcome is the incidence of bleeding events occurring during the study period of 135 days (including follow-up). Major bleeding events and clinically relevant non-major bleeding events were defined according to accepted guidelines.
The purpose of this post-marketing surveillance study is to collect and assess information retrospectively on safety and effectiveness of fondaparinux injection in patients with venous thromboembolism (VTE) whose body weight is 100 kilograms (kg) or more, or to whom fondaparinux was injected 10 mg/day. ("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
The purpose of this post-marketing surveillance study is to collect and assess information on safety and efficacy of fondaparinux injection in patients with venous thromboembolism (VTE). ("Arixtra" is a trademark of the GlaxoSmithKline group of companies.)
This post-marketing surveillance study was designed to collect and assess the information on proper use of fondaparinux injection, such as the safety and efficacy under actual use conditions, in subjects undergoing orthopedic surgery of the lower limb at high risk of developing venous thromboembolism. (ARIXTRA® is a trademark of the GlaxoSmithKline group of companies.)
The Angel™ Catheter combines the functions of a vena cava filter and a multi-lumen central line catheter. The device is designed to be placed in the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The primary endpoint is freedom from serious adverse events (SAE), defined as death, symptomatic pulmonary embolism or major bleeding .