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Thromboembolism clinical trials

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NCT ID: NCT01452568 Completed - Bleeding Clinical Trials

Anticoagulant After Implantation of Biological Aortic Valve Comparing With Aspirin

Start date: June 2005
Phase: Phase 4
Study type: Interventional

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.

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: NCT01420809 Completed - Thromboembolism Clinical Trials

Special Drug Use Investigation for ARIXTRA® (Fondaparinux) Injection

Start date: September 2007
Phase: N/A
Study type: Observational

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.)

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: NCT01370278 Completed - Clinical trials for Myocardial Infarction

Clearance Of Mucus In Stents (COMIS)

Start date: June 16, 2011
Phase: N/A
Study type: Interventional

The goal of this clinical research study is to compare the effects of sodium bicarbonate to normal saline when used for clearing mucus blockage in patients with airway stents.

NCT ID: NCT01366599 Completed - Vomiting Clinical Trials

CV Events in Emetogenic Chemotherapy

Start date: May 2009
Phase: N/A
Study type: Observational

Describe cardiovascular events in a cancer population receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC).

NCT ID: NCT01362933 Completed - Neoplasms Clinical Trials

National Evaluation of the Adherence to Recommendations of Venous Thrombo Embolism Treatment in Cancer Patients

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

Treatment of venous thromboembolism in cancer patients is specific and has been validated in trials that favor the use of LMWH (Low Molecular Weight Heparin) instead of VKA (Vitamin K Antagonist) treatment during 6 months. International recommendations have diffused this option.It is necessary to evaluate the compliance of physicians to this treatment by measuring the number of patients with cancer treated with long term use of LMWH.