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Venous Thromboembolism clinical trials

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NCT ID: NCT01446510 Withdrawn - Clinical trials for Venous Thromboembolism

Systematic Review and Meta-Analysis of Venous Thromboembolism (VTE) Risk Assessment in Hospitalized Medical Patients

Start date: September 2011
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01444586 Completed - Clinical trials for Arthroplasty, Replacement, Knee

Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)

SOPRANO
Start date: October 2011
Phase: N/A
Study type: Observational

This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.

NCT ID: NCT01431456 Completed - Clinical trials for Venous Thromboembolism

Safety of DAbigatran and RIvaroxaban Versus NAdroparin in the Prevention of Venous Thromboembolism After Knee Arthroplasty Surgery

DARINA
Start date: September 2013
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT01428544 Completed - Ataxia Clinical Trials

Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg)

Start date: March 2012
Phase: N/A
Study type: Observational

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.)

NCT ID: NCT01428531 Completed - Ataxia Clinical Trials

Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment

Start date: January 2012
Phase: N/A
Study type: Observational

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.)

NCT ID: NCT01403090 Completed - Pulmonary Embolism Clinical Trials

Safety Study of the Angel™ Catheter in Subjects With Risk of Pulmonary Embolism

Start date: December 2011
Phase: Phase 1
Study type: Interventional

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 .

NCT ID: NCT01401725 Completed - Clinical trials for Venous Thromboembolism

Electronic Strategies to Enhance Venous Thromboemboli (VTE) Prophylaxis in Hospitalized Medical Patients

E-SENTRY
Start date: April 2011
Phase: N/A
Study type: Interventional

Venous thromboemboli (VTE) are abnormal blood clots that commonly form in the blood vessels of the legs or lungs. They can block normal blood flow, damage organs, and even cause death. The risk of VTE is increased in people who are sick or immobile. VTE is the most common preventable cause of death in hospitalized patients, and its VTE prevention should be a top patient safety priority. Though there is good evidence that injectable blood thinners and/or compression stockings can prevent VTE, over 30% of hospitalized medical patients in Hamilton, Ontario receive inappropriate prevention. Hamilton Health Sciences Corporation is in the process of introducing "electronic order sets" - computer programs that help doctors order medications and other healthcare interventions for their patients. The investigators would like to study if these electronic order sets can help improve the rate of appropriate VTE prevention in hospitalized medical patients. The investigators will examine the rate before and after the introduction of electronic order sets at the Juravinski Hospital and the Hamilton General Hospital. Doctors at the Hamilton General Hospital will also get to use an additional computer program, called a computerized decision support system (CDSS), that helps them decide on the best strategy to prevent VTE in individual patients. The rates of VTE prevention at each hospital will be compared to each other, and to the rates at St. Joseph's Healthcare Hamilton, which will receive neither the order sets nor the CDSS.

NCT ID: NCT01372514 Recruiting - Pulmonary Embolism Clinical Trials

Institutional Registry of Thromboembolic Disease

IRTD
Start date: August 2006
Phase:
Study type: Observational

The purpose of this study is to create an institutional registry of Thromboembolic disease through a prospective survey based on epidemiological data, risk factors, diagnosis, prognosis, treatment, monitoring and survival. The main goal is to describe the occurrence of thromboembolic disease and the characteristics of clinical presentation, evolution and predisposing factors of these episodes in the population of the Hospital Italiano de Buenos Aires.

NCT ID: NCT01367184 Terminated - Clinical trials for Venous Thrombo-embolism

National Inferior Vena Cava (IVC) Filter Registry

Start date: May 2011
Phase: N/A
Study type: Observational

Inferior vena cava (IVC) filter is an important therapeutic device used in the management of venous thrombo-embolism (VTE) in patients that are contra-indicated for anti-coagulation therapy. While there has been significant increase in the use of filters , unfortunately there are no standardized collection of data to track, compare outcomes, report safety and efficacy.

NCT ID: NCT01363193 Recruiting - Obesity Clinical Trials

Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients

Start date: July 2011
Phase: N/A
Study type: Interventional

Standard weight-based IV heparin for normal weight patients is based on actual body weight (ABW). However, no well-defined guidelines have been established for patients considered to be obese or morbidly obese. In current practice, the calculated ABW based heparin initial bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly obese patients for fear of bleeding. Heparin is distributed in the body approximately the same as blood and does not get distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW) might be a better basis for dosing heparin. LBW is a calculated weight that excludes the weight of fat. The investigators hypothesize that intravenous heparin dosing based on the Lean body weight of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level of heparin in 24 hours compared to the usual practice in this patient population.