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Venous Thromboembolism clinical trials

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NCT ID: NCT01835990 Completed - Trauma Clinical Trials

Feasibility Study of Geko vs. IPCs in Trauma

GIFT Pilot
Start date: July 2013
Phase: Phase 2
Study type: Interventional

Trauma patients are at a high risk of developing blood clots in the legs (deep vein thrombosis - DVT), which can travel to the lungs and cause serious health consequences. Often, these patients cannot receive blood-thinning medication to prevent these blood clots because of the risk of bleeding; in this case, they are usually given intermittent pneumatic compression devices (IPCs) to prevent blood clots. IPCs are inflatable sleeves that fit over the legs and periodically inflate and deflate, helping to pump blood out of the legs and thus reduce the risk of blood clot formation. Several studies suggest that IPCs are working properly on the patient only 60-70% of the time. Some patients also find them uncomfortable. A new device (geko) that works by stimulating the leg muscles and increasing blood flow in the legs has recently been developed. To compare the geko with IPCs, this study will randomly assign trauma patients who cannot receive blood thinners for blood clot prevention to either IPCs or geko. The main goal is to determine the feasibility of doing a larger study which would compare the efficacy of these devices in preventing blood clots. The amount of time the devices are properly used on the patients, comfort and tolerability, development of blood clots, and blood flow in the leg veins and arteries will also be measured and compared between the devices.

NCT ID: NCT01809015 Completed - Atrial Fibrillation Clinical Trials

Evaluation of Oral Anticoagulation With Vitamin K Antagonists - The thrombEVAL Study Programme

thrombEVAL
Start date: January 2011
Phase:
Study type: Observational

Since decades, oral anticoagulation (OAC) with vitamin K antagonists (VKA) is an established therapy for both prevention and treatment of thromboembolism in daily clinical routine. Increasing life-expectancy, the demographic change and novel oral anticoagulants lead to an increasing complexity of medical therapy. However, data on quality and management of VKA therapy with phenprocoumon in current medical care are limited. Our aim was to investigate the quality of OAC with VKA in current health care and to evaluate the potential for improvements. The investigator-initiated thrombEVAL study program comprises two cohorts of patients treated with vitamin K antagonists for oral anticoagulation therapy in real-life settings: a multicentre cohort of patients in regular medical care and a multi-local, single centre cohort of patients in a telemedicine-based coagulation service. The study program is expected to enrol a total number of approximately 2,000 to 2,500 patients. Both cohorts build on a detailed clinical assessment of participants and anticoagulation therapy at study enrolment. Subsequently active and passive follow-up investigations are carried out to document and validate complications of the treatment. Primary short-term outcome is the distribution of time in therapeutic range; the primary long-term outcome comprises the composite of stroke, systemic embolism, myocardial infarction, major and clinically-relevant bleeding and death.

NCT ID: NCT01803022 Completed - Clinical trials for Venous Thromboembolism

Prescription and Utilization of Low Molecular Weight Heparin in Usual Medical Practice for the Curative Treatment of Venous Thromboembolism in Patients With Cancer

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

The study purpose is to document the prescription and the use of Low Molecular Weight Heparin in usual medical practice in patients with cancer and established Venous Thromboembolism. This study also aims at gathering epidemiological data on the Low Molecular Weight Heparin therapy of Venous Thromboembolism in patients with cancer.

NCT ID: NCT01781858 Completed - Clinical trials for Cardiovascular Diseases

Study on the Clinical Course Of Pulmonary Embolism

SCOPE
Start date: January 2008
Phase: N/A
Study type: Observational

The course of both pulmonary embolism (PE) and one of its more relevant late complications, i.e. chronic thromboembolic pulmonary hypertension (CTEPH) is still substantially unknown. Recent evidence has shown that the incidence of CTEPH is higher than previously believed, but this has not been confirmed by other studies. A clear link between PE and CTEPH has been questioned by some experts. A great number of patients affected by PE persistently have residual chronic thromboembolic material the meaning of which is a matter of debate. The evidence sustaining a link between chronic residual PE and subsequent PE recurrences or CTEPH is insufficient. Thus, a nationwide, multicentre, prospective cohort study was designed with the following aims: 1. to ascertain the incidence of symptomatic CTEPH after a first episode of acute PE; 2. to ascertain the incidence of venous thromboembolic (VTE) recurrences after a first episode of acute PE; 3. to evaluate whether a relation exists between chronic residual PE and CTEPH 4. to evaluate whether a relation exists between chronic residual PE and VTE recurrences; 5. to evaluate whether a relation exists between persistent right ventricular dysfunction and CTEPH; 6. to evaluate whether a relation exists between persistent right ventricular dysfunction and PE recurrences. For each enrolling centre, consecutive outpatients or inpatients with an objectively diagnosed first acute PE episode are considered eligible.

NCT ID: NCT01744431 Completed - Clinical trials for Venous Thromboembolism

Can Thrombin Generation Measurement Predict the Risk of Venous Thromboembolism in Acute Ill Patients

Start date: December 2012
Phase: N/A
Study type: Observational [Patient Registry]

Can thrombin generation measurement predict the risk of venous thromboembolism in acute ill patients Traditional coagulation tests do not assess the whole coagulation system. Thrombin generation assays measure the ability of plasma sample to generate thrombin following in vitro activation of coagulation. In contrast to the classical clotting assays, thrombin generation reflects and integrates all pro and anticoagulant reactions that regulate the formation and inhibition of thrombin. The aim of our study is to investigate whether thrombin generation would be able to predict a hypercoagulable state in acute ill patients admitted in the internal medical departments and how it correlates with the Padua prediction score, a score that could assists the risk for venous thromboembolism in hospitalized medical patients. In total 300 patients are planned for inclusion in this trial. After signing an informed consent a blood sample will be obtained from each participant. We will measure the thrombin generation over time in plasma assessed by the calibrated automated thrombogram (CAT).

NCT ID: NCT01720108 Completed - Clinical trials for Venous Thromboembolism

Extended Venous Thromboembolism Prophylaxis Comparing Rivaroxaban to Aspirin Following Total Hip and Knee Arthroplasty

EPCAT II
Start date: February 24, 2013
Phase: Phase 3
Study type: Interventional

In this study the investigators want to look at whether using aspirin instead of rivaroxaban (after initial treatment with rivaroxaban) works as well at preventing blood clots while also reducing risk of bleeding and is more cost effective in patients who have either a total hip replacement or total knee replacement.

NCT ID: NCT01713361 Completed - Clinical trials for Venous Thromboembolism

Active Comparator-Controlled Study to Assess Safety and Efficacy of ISIS-FXIRx in Total Knee Arthroplasty

Start date: October 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is: - To assess the safety and efficacy profile of ISIS-FXIRx, including incidence of bleeding and VTE, in patients undergoing total knee arthroplasty. - To compare the efficacy and safety profile of ISIS-FXIRx in patients who achieve less than or equal to 0.2 U/mL FXI activity levels to that of enoxaparin.

NCT ID: NCT01653405 Completed - Atrial Fibrillation Clinical Trials

Improving Anticoagulation Control in VISN 1

Start date: October 1, 2014
Phase: N/A
Study type: Interventional

Over 100,000 VHA patients receive anticoagulants (blood thinners) each year to prevent blood clots (including strokes). Too much anticoagulation increases the risk of serious or even fatal bleeding, and too little anticoagulation fails to protect the patient against blood clots. VHA anticoagulation clinics vary widely on how much time their patients spend in the therapeutic range, the range within which they are protected from clots but not at excessive risk of bleeding. Anticoagulation clinics can improve anticoagulation control by following several relatively simple procedures, including following-up promptly when patients are out of range and focusing on educating and supporting patients with poor control. In this study, the investigators will promote these practices at the anticoagulation clinics of the New England VA region, with a goal of improving anticoagulation control.

NCT ID: NCT01629381 Completed - Clinical trials for Venous Thromboembolism

Efficacy of RIvaroxaban for Prevention of Venous Thromboembolism After Knee Arthroscopy

ERIKA
Start date: May 2012
Phase: Phase 2
Study type: Interventional

Study Objective: To assess the value of Rivaroxaban for the prevention of venous thromboembolism (VTE) after knee arthroscopy (KA) taking the placebo as standard of reference. Study Population: Patients undergoing therapeutic KA at the study Centers, irrespective of the type and duration of the procedure, will be eligible for the study. Study Design: Multicenter, randomized, double blind superiority, phase II trial comparing two arms: - (R-7d) Rivaroxaban (10 mg od os) for 7 days - (PL-7d) Placebo for 7 days. Follow-up: 3-month period after the randomization Standard of Reference:Placebo will be the standard of reference in accordance to international guidelines Study length May 2012-December 2012 Total patients number: 500 patients Primary Efficacy End-Point: Occurrence in the 3-month period after the randomization of at least one of the following events, objectively proven (by means of CCDU; multi-slice chest TC-angio; autopsy, if necessary, or clinical ground): - All-cause mortality - Symptomatic VTE - Asymptomatic proximal DVT Secondary Efficacy End-point: • Combined incidence of all DVT plus symptomatic PE Primary Safety End-point: Incidence of major bleedings. Secondary Safety End-point: Overall incidence of bleeding

NCT ID: NCT01619007 Completed - Clinical trials for Deep Vein Thrombosis

Treatment of an Acute Deep Vein Thrombosis (DVT) With Either Rivaroxaban or Current Standard of Care Therapy

XALIA
Start date: June 2012
Phase: N/A
Study type: Observational

Following the findings of the clinical trials in drug development, this global non-interventional cohort field study will investigate rivaroxaban under clinical practice conditions in comparison with current standard of care for patients with acute deep vein thrombosis (DVT). The main goal is to analyze long-term safety in the use of rivaroxaban in the treatment of acute DVT in routine clinical practice.