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Venous Thrombosis clinical trials

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NCT ID: NCT01064362 Completed - Thrombosis, Venous Clinical Trials

Hemorrhage Risk Prescribed Arixtra

Start date: January 2010
Phase: N/A
Study type: Observational

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.

NCT ID: NCT01037270 Completed - Atrial Fibrillation Clinical Trials

Evaluation of the Accuracy and Precision of the INRatio® Prothrombin Time (PT) Monitoring System With New INRatio Test Strip Designed for Low Sample Volume and Heparin Insensitivity

ECLIPSE-01
Start date: August 2009
Phase: N/A
Study type: Observational

This is a multi-center study designed to evaluate the accuracy and precision of the INRatio® Prothrombin Time (PT) Monitoring System, utilizing the INRatio test strip newly designed for low sample volume and heparin insensitivity, when used by trained medical professionals for the quantitative determination of PT and International Normalized Ratio (INR) in fingerstick and venous whole blood from subjects on oral anticoagulation therapy (OAT). These results will be compared to those PT/INR results obtained on plasma from the same subjects as analyzed at a central laboratory with the Sysmex CA-560 System.

NCT ID: NCT01007045 Completed - Clinical trials for Deep Vein Thrombosis

Limited Compression Ultrasound by Emergency Physicians to Exclude Deep Vein Thrombosis

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

Deep vein thrombosis is a common condition seen in the Emergency Department. Standard of care for diagnosis of DVT includes a combination of a clinical pre-test probability rule known as Well's criteria, D-dimer blood testing, and Radiology department ultrasound. The purpose of this study is to determine whether Emergency Physicians can safely rule out deep vein thrombosis using Well's criteria and D-dimer blood testing combined with Emergency department bedside ultrasound.

NCT ID: NCT00986154 Completed - Clinical trials for Venous Thromboembolism

Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots. (The Edoxaban Hokusai-VTE Study).

Start date: October 2009
Phase: Phase 3
Study type: Interventional

Evaluation of heparin/edoxaban tosylate (DU176b) versus heparin/warfarin in preventing recurrence of blood clots in patients with acute symptomatic deep-vein blood clots in the legs and/or blood clots in the lungs.

NCT ID: NCT00967148 Completed - Cancer Clinical Trials

Thromboprophylaxis for Patients Undergoing Surgical Resection for Colon Cancer

PERI-OP
Start date: June 2009
Phase: N/A
Study type: Interventional

The blood thinner "tinzaparin" might increase survival in patients with colon cancer undergoing surgical resection. The investigators want to assess if a trial allocating patients to prolonged treatment with tinzaparin versus standard of care is feasible.

NCT ID: NCT00924859 Completed - Clinical trials for Cerebral Venous Thrombosis

The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)

Start date: September 2009
Phase:
Study type: Observational

The investigators aim to assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test, to exclude CVT in patients with clinical suspicion of CVT.

NCT ID: NCT00911157 Completed - Thrombosis, Venous Clinical Trials

The Treatment of Acute Deep Vein Thrombosis (DVT) of GSK576428 (Fondaparinux Sodium) in Japanese Patients

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute symptomatic DVT in an open-label design.

NCT ID: NCT00910364 Completed - Clinical trials for Deep Vein Thrombosis

Feasibility Study of Exercise in Patients With Leg Blood Clots

EXPERT
Start date: October 2008
Phase: N/A
Study type: Interventional

The purpose of this pilot study is to assess the feasibility of determining the effects of a structured exercise program started two to four weeks after diagnosis of a first episode lower-extremity deep vein thrombosis (DVT) for a period of 12 weeks in reducing the incidence of post-thrombotic syndrome (PTS).

NCT ID: NCT00905177 Completed - Atrial Fibrillation Clinical Trials

Predictors of Anticoagulation Control on Warfarin Therapy

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

The goal of this research study is to develop better dosing of anticoagulation medication in both Caucasian and African Americans through analysis of various genetic factors.

NCT ID: NCT00904982 Completed - Atrial Fibrillation Clinical Trials

Randomized Trial of Interventions to Improve Warfarin Adherence

WIN3
Start date: October 2009
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to see if a lottery which provides the opportunity to win money, a reminder system using a "Med-eMonitor", or the combination of both might be useful in helping patients to achieve better control of their anticoagulation therapy. Selection for the arms of the study is randomized by the study computer. Some will participate in the daily lottery only, some with the reminder system only, some with the reminder system and the daily lottery, and some with neither the lottery nor the reminder system.