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Deep Vein Thrombosis clinical trials

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NCT ID: NCT00334464 Completed - Atrial Fibrillation Clinical Trials

A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"

Start date: February 2006
Phase: N/A
Study type: Interventional

Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention. It is a leading cause of iatrogenic bleeding events and, hence, of malpractice claims. There are no good alternatives presently for warfarin anticoagulation, and even when alternatives become available (i.e., ximelagatran), cost, labeling, and experience (outcomes-related) issues will continue to favor an extensive and ongoing use of warfarin. If the present study is able to confirm an advantage for a genotype-driven algorithm, in terms of improved efficiency, therapeutic efficacy, and, especially, safety, then a pharmacogenetics approach to warfarin dosing can be recommended as the basis for an Intermountain Health Care (IHC)-wide quality improvement initiative that should improve patient outcomes, reduce resource use (costs of achieving safe and therapeutic anticoagulation), and reduce adverse clinical events. COUMA-GEN is a prospective, randomized study of patients who are to begin chronic warfarin therapy for specific, qualifying clinical reasons (i.e., atrial fibrillation (AF), deep vein thrombosis (DVT), or post-orthopedic surgery prophylaxis). Qualifying patients will be consented and randomized to an individualized, genotype-based warfarin-dosing regimen or to standard care (without knowledge of genotype). In each study arm, a predicted maintenance dose will be determined. All patients will receive a baseline International Normalized Ratio (INR). For patients in all 3 entry strata, a starting dose of warfarin that is twice the assigned daily maintenance dose (according to the specific treatment arm) will be prescribed on the first and second days, and then the dose will revert to the assigned maintenance dose.

NCT ID: NCT00333697 Completed - Clinical trials for Deep Vein Thrombosis

Single Comprehensive Ultrasound to Rule Out DVT in High-risk Patients

Start date: November 2005
Phase: N/A
Study type: Interventional

To determine the rate of thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld on the basis of a negative comprehensive duplex ultrasound examination. Participants are followed for three months after a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis develop. Any such symptoms are verified by objective tests.

NCT ID: NCT00314990 Completed - Pulmonary Embolism Clinical Trials

VITRO-Trial. B Vitamins and the Secondary Prevention of Venous Thrombosis

Start date: January 1996
Phase: N/A
Study type: Interventional

The VITRO (Vitamins and Thrombosis) study investigated the effect of homocysteine lowering by daily supplementation of B-vitamins on the risk reduction of deep-vein thrombosis and pulmonary embolism. Patients between 20 to 80 years old with a first objectively confirmed proximal deep-vein thrombosis or pulmonary embolism in the absence of major risk factors and a homocysteine concentration above the 75th percentile of a reference group were asked to participate (hyperhomocysteinemic group). A similar study was conducted in a random sample of patients with a homocysteine below the 75th percentile of the reference group (normohomocysteinemic group). After informed consent patients were randomized to daily multivitamin supplementation (5 mg folic acid, 50 mg pyridoxine and 0.4 mg cyanocobalamin) or placebo and were followed for 2.5 years. End-points were objectively diagnosed recurrent deep-vein thrombosis or pulmonary embolism.

NCT ID: NCT00285038 Completed - Clinical trials for Deep Vein Thrombosis

Ultrasound (US)-Doppler for the Diagnosis of Asymptomatic Deep Vein Thrombosis (DVT) in Gynecologic Cancer Patients

Start date: March 2006
Phase: Phase 2
Study type: Observational

The aim of this study is to determine the prevalence of asymptomatic lower extremity DVT detected by Doppler ultrasound in a selected group of patients suffering from gynecological malignancies.

NCT ID: NCT00277394 Completed - Clinical trials for Deep Vein Thrombosis

Innohep® in Elderly Patients With Impaired Renal Function Treated for Acute Deep Vein Thrombosis

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

The objective of the study is to compare the safety of innohep® and Unfractionated Heparin (UFH) in terms of clinically relevant bleedings in elderly patients with impaired renal function for initial treatment of acute Deep Venous Thrombosis (DVT). The primary response criterion is the percentage of patients with clinically relevant bleeding events prior to day 90 +/- 5.

NCT ID: NCT00266045 Completed - Pulmonary Embolism Clinical Trials

D-dimer Levels During and After Anticoagulation in Patients With a Previous Venous Thromboembolism: Effects on the Risk of Recurrence

Start date: August 2005
Phase:
Study type: Observational

The results of the Prolong study, currently submitted for publication, show that patients with a first unprovoked venous thromboembolic event who have altered D-dimer levels, measured one month after anticoagulation with vitamin K antagonists is stopped, have a high rate of recurrences (about 14%) and a prolongation of anticoagulation is effective in reducing significantly this rate. Those patients with normal D-dimer (about 60% of all patients examined) have a low rate of recurrences (about 5%) and likely a prolongation of anticoagulation in all these patients cannot be recommended. In line with these results, the Prolong-Two study aims at assessing the predictive role for recurrence of D-dimer levels measured: a) during anticoagulation, b) one month after its withdrawal and c) periodically during follow up. Patients with a first unprovoked venous thromboembolism (including proximal deep vein thrombosis of a leg and/or pulmonary embolism) which are treated with vitamin K antagonists for not less than 6 months are considered for the study. D-dimer assay is performed during anticoagulation and patients with altered results continue the anticoagulation for 6 more months. Those with normal D-dimer stop the anticoagulant treatment and are again examined one month later. Anticoagulation is resumed for 6 more months in those patients with abnormal D-dimer results but is permanently stopped in those with a normal assay. The latter patients are examined and D-dimer assay performed again every two months to evaluate the natural history of the assay after anticoagulation is stopped and the possible predictive value for recurrence of a change of the assay during follow-up from normal to abnormal results.

NCT ID: NCT00264277 Completed - Pulmonary Embolism Clinical Trials

D-dimer to Establish Duration of Anticoagulation After Venous Thromboembolism

Start date: September 2002
Phase: Phase 4
Study type: Interventional

The optimal duration of oral anticoagulant treatment in patients with idiopathic venous thromboembolism is still uncertain. The present study addresses the possible role of the D-dimer test in assessing the need for continuation of anticoagulation.The study aims at assessing whether D-dimer assay may have a role in guiding the duration of anticoagulation in these patients

NCT ID: NCT00261014 Active, not recruiting - Clinical trials for Deep Vein Thrombosis

Understanding Risk Factors Involved in Developing a Second Blood Clot.

Start date: October 2002
Phase: N/A
Study type: Observational

The purpose of this study is to develop a way to predict which patients diagnosed with idiopathic blood clots can safely stop warfarin therapy after six months. We will use patient characteristics, blood test results and imaging test results to identify those patients who have the lowest risk of developing a new blood clot after warfarin is stopped.

NCT ID: NCT00252005 Completed - Clinical trials for Deep-Vein Thrombosis

Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study

Start date: November 2005
Phase: Phase 2
Study type: Interventional

The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.

NCT ID: NCT00251771 Completed - Clinical trials for Deep Vein Thrombosis

Catheter-Directed Venous Thrombolysis in Acute Iliofemoral Vein Thrombosis

CaVenT
Start date: January 2006
Phase: N/A
Study type: Interventional

Deep vein thrombosis (DVT) is a severe disease, and conventional treatment with low molecular weight heparin (LMWH) and warfarin is associated with some degree of long-term sequelae, i.e. post-thrombotic syndrome (PTS). Catheter-directed thrombolytic (CDT) therapy has been introduced worldwide the last two decades. Reports have suggested a beneficial effect of this costly treatment, but there are no randomized clinical trials documenting its short- and long-term efficacy and safety. This multi-center study will randomize patients with acute iliofemoral vein thrombosis to either conventional treatment or CDT in addition to conventional treatment. Main outcome parameters are patency rates at 6 months and prevalence of PTS at 24 months. The main short-term hypothesis is that CDT of first-time acute DVT will increase patency of the affected segments after 6 months from <50% to >80%. The main long-term hypothesis is that CDT will improve long-term functional outcome, i.e. risk of PTS after 2 years from >25% to <10%.