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Venous Thromboembolism clinical trials

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NCT ID: NCT00291330 Completed - Thromboembolism Clinical Trials

Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

RE-COVER I
Start date: February 2006
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

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: NCT00246025 Completed - Clinical trials for Arthroplasty, Replacement, Knee

A Study of BIBR 1048 in Prevention of Venous Thromboembolism in Patients With TKR Surgery.

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

The goal of this study is to evaluate the comparative efficacy and safety of three different doses ( 110 mg, 150 mg, 220 mg) of BIBR 1048 (Dabigatran etexilate) orally, compared to placebo, in prevention of venous thromboembolism in patient with primary elective total knee replacement surgery, and to evaluate dose-response.

NCT ID: NCT00244725 Completed - Pulmonary Embolism Clinical Trials

Odiparcil For The Prevention Of Venous Thromboembolism

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

Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

NCT ID: NCT00219973 Completed - Cancer Clinical Trials

CANBESURE STUDY (Cancer, Bemiparin and Surgery Evaluation)

Start date: May 2005
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate the efficacy and safety of Bemiparin, a second-generation LMWH, in the prophylaxis of VTE (using a postoperative regimen, i.e. administering the first dose 6 hours after finishing the surgical procedure) for 28 days compared to 8 days, in oncological surgery.

NCT ID: NCT00201903 Completed - Clinical trials for Venous Thromboembolism

The Roles of Tissue Factor in Malignant Gliomas

Start date: January 2004
Phase: N/A
Study type: Observational

To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

NCT ID: NCT00196118 Completed - Pulmonary Embolism Clinical Trials

Study of IVC Filter Retrieval With the Günther Tulip Vena Cava Filter

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

The purpose of this study is to test the hypothesis that the Günther Tulip Vena Cava Filter can be removed after a period of implantation, when implanted in patients for the prevention of pulmonary thromboembolism.

NCT ID: NCT00182403 Completed - Pulmonary Embolism Clinical Trials

Fixed Dose Heparin Study

Start date: September 1998
Phase: Phase 3
Study type: Interventional

FIDO was a multicentred randomized, open-label trial that compared fixed-dose UFH with fixed-dose LMWH for initial treatment of VTE. Patients were followed for 3 months during which they received warfarin (target INR 2.0-3.0).

NCT ID: NCT00182221 Completed - Clinical trials for Venous Thromboembolism

Safety of a Diagnostic Strategy With D-Dimer Testing for PE

Start date: August 2003
Phase: Phase 3
Study type: Interventional

To determine whether D-Dimer testing, using the MDA D-Dimer assay, can be used to simplify the diagnostic process for pulmonary embolism (PE). This will be assessed by performing a cohort study in 1000 patients with suspected PE. To ascertain if an MDA D-Dimer result of less than 0.75 ug/mL FEU obviates the need for further testing and therapy in patients with suspected PE.