View clinical trials related to Embolism.
Filter by:The primary objective of this trial is to evaluate the safety and efficacy of treatment with anticoagulation alone versus anticoagulation and mechanical aspiration thrombectomy with the Indigo Aspiration System for the treatment of intermediate-high risk acute pulmonary embolism (PE).
Prospective, randomized, open label, multicenter, 2-arm, safety and efficacy study
The primary objective of this investigation is to compare the efficacy of two different antithrombotic strategies after percutaneous LAA occlusion with a Watchman device on the prevention of silent cerebral embolism.
Evaluation of initial safety and clinical feasibility of the Viper Catheter System for thrombectomy in acute submassive pulmonary embolism (PE).
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.
The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.
To research and develop new state of the art diagnostic biomarkers on the LumiraDx Platform that are comparable to the approved gold standard reference methods and will radically enhance clinicians and patients ability to monitor health conditions and improve outcomes by delivering the results near patient at the point of care.
This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis. The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outcome was major bleeding.
Pulmonary Embolism(PE) requires multidisciplinary approach as a highly morbid and mortal disease. This multidisciplinary approach creates clinical benefits in diagnostic and therapeutic process. And these benefits are pointed out in certain studies and guidelines. For these reasons, a Pulmonary Embolism Response Team (PERT) was established on 5 th November 2018 which is called as Ege Pulmonary Embolism Team (EGEPET) in our university. In recent years, it is stated that the carefully use of thrombolytic in patients with intermediate-high risk PE based on early mortality classification. Some studies have reported that the use of thrombolytic may cause clinical benefits. But which used drug and which dose are not defined clearly yet. After establishment of EGEPET, the investigators observed that patients with intermediate-high risk PE more receive reduced dose thrombolytic than the pre-EGEPET period. And the investigators aimed to compare treatment changes after and before the establishment of EGEPET. Also, the investigator will compare initial reduced dose thrombolytic therapy after EGEPET with initial anticoagulation therapy before EGEPET (historical group) in terms of mortality and complication. As the reduced dose thrombolytic, Alteplase 50 mg is used in our hospital. Low-molecular weight heparin (LMWH), standard heparin and rarely Fondaparinux are used for anticoagulation therapy. Low-molecular weight heparin is generally applied for treatment, in case there is no contraindication. Our primary end-point is to assess 30-day mortality and secondary-end points are to detect in one year-mortality and complications. The investigators will compare the mortality and complication rates in these groups. N0 hypothesis; In the intermediate-high risk group diagnosed with PE, there is an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature. N1 hypothesis; In the intermediate-high risk group diagnosed with PE, there is no an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
Background: Intermediate-high risk acute pulmonary embolism (PE) remains associated with substantial mortality despite standard anticoagulation therapy. Previous efforts to decrease mortality in these patients via administration of systemic thrombolysis have failed due to an increased rate of major bleeding complications. Catheter-directed thrombolysis (CDT) has already shown some promising results in terms of efficacy and safety, including the results of our randomized pilot study. However, large randomized trials with clinical endpoints comparing catheter-directed local thrombolysis versus standard anticoagulation therapy are still lacking, thus the treatment of intermediate-high risk acute PE patients has not changed for decades. Hypothesis: Catheter-directed local thrombolysis is superior to standard anticoagulation therapy in the treatment of intermediate-high risk acute pulmonary embolism, with no additional safety concerns. Statistical considerations: Estimated incidence of the primary endpoint of 1.5% in the CDT group and 6.0% in the standard anticoagulation group, 80% power for each arm with a 2-sided alpha of 0.05. Five hundred fifty-eight should provide the requisite number of events. Statistical Analysis - Intention to Treat. Methods and Results: A Multicentre, Randomized Trial of Catheter-directed thrombolysis in intermediate-high risk acute pulmonary embolism (PRAGUE-26) is a noncommercial, multicentre, randomized, controlled parallel-group comparison trial. The trial plans to include 558 patients with intermediate-high risk acute PE. Patients will be randomized in a 1:1 ratio to CDT or to standard anticoagulation therapy. The primary outcome of the study is a clinical composite of all-cause mortality, PE recurrence or cardiorespiratory decompensation, within 7 days of randomization. Secondary objectives cover all bleeding complications, functional and patient-reported outcomes over a follow-up period of 24 months and cost-effectiveness analysis.