Active clinical trials for "Thrombosis"

To characterize the pharmacokinetic profile of rivaroxaban administered as granules for suspension formulation and to document safety and tolerability

The study objective is to investigate the pharmacodynamics (effects of a drug product) when switching the treatment from warfarin to rivaroxaban. 84 young, healthy subjects will participate; they will be treated following a randomized, parallel-group (Treatments A, B, and C), placebo-controlled (Treatment B), and single-blind (Treatments A and B) design. The first two groups (A, B) will receive warfarin for approximately one week to adjust their blood coagulation values to a specific level, i.e. to maintain an INR (international normalized ratio) of 2.0 - 3.0. This range is commonly used for long-term anticoagulant treatment. The first group (A) will receive rivaroxaban for four days, the second group (B) will take placebo. On the last day, all subjects in groups A and B will receive vitamin K to neutralize the effects of warfarin. The third group (C) will not undergo prior treatment with warfarin but will receive rivaroxaban for four days.

The objective of the SAFE K study is to demonstrate that in patients treated with the antagonists of vitamin K (VKA), a daily intake of vitamin K2 (75 micrograms/day) as naturally produced by the ferments used in fermented dairy products, does not upset the balance of anticoagulant treatment.Fifty-two patients will be chosen to receive either verum or placebo for four months after a 4-month run-in period.In addition, the study evaluates if regular consumption of vitamin K2 reduce the need of changing the dose of anticoagulation treatment and improve the markers of bone mineralisation.

The standard treatment of advanced hepatocellular carcinoma (HCC) is sorafenib. Though the agent showed clear survival benefit in two randomized phase III trials, the benefit was modest and response rate was just a few percent. Therefore, other loco-regional modalities, like trans-arterial chemo-embolization (TACE), hepatic arterial infusion chemotherapy (HAIC), and radiotherapy (RT) were continuously tried, especially in locally advanced HCC including portal vein tumor thrombosis (PVTT). With the advancement of conformal RT techniques, RT was actively applied in HCC, especially in PVTT combined HCC. Many researchers reported that there is a relationship between RT dose and tumor response rate. RT dose, however, is frequently limited because the complications (like radiation induced liver disease (RILD), radiation induced gastro-duodenal toxicity, etc.) are also closely related with higher exposed RT dose. Proton beam has characteristic depth-dose distribution contrast to photon, the "Bragg peak". The advantage of this dose distribution could be more highlighted in HCC management, because of the weakness and maintenance importance of liver function itself in HCC patients. In fact, the superior results of proton beam therapy in HCC were constantly reported in several groups as prospectively as well as retrospectively. In those background, the investigators planned the present study to evaluate the efficacy and safety of proton beam therapy in HCC patients combined with PVTT.

TACT is a "real world" randomized controlled trial of tecarfarin, a novel vitamin K antagonist, vs. warfarin. The quality of anticoagulation control will be compared for the two groups of subjects who require chronic oral anticoagulation for a broad panel of indications.

This study is designed to determine the safety, pharmacokinetics and pharmacodynamics of a single intravenous dose of TS23 in healthy adults.

The purpose of this study is to evaluate the effectiveness of a new leg compression device in preventing post-surgical deep vein thrombosis (blood clot) that can occur after major and complex spine surgery. The investigators aim to show that this new compression device is no worse than the standard sequential compression device (SCD) at preventing DVT and may be able to detect deep vein thrombosis in patients who are not typically screened for this diagnosis after surgery. This new device may be able to capture an important post-surgical complication while providing a more comfortable treatment option.

The purpose of this clinical randomized trial is to evaluate the efficacy and safety of rivaroxaban compared with warfarin in dissolving the LAA thrombus in patients with atrial fibrillation.

In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.

Inflammatory diseases favour the onset of venous thromboembolic events in hospitalized patients. Thromboprophylaxis with a fixed dose of heparin/low molecular weight heparin (LMWH) is recommended if concomitant inflammatory disease. In severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) pneumonia an inflammation-dependent thrombotic process occurs and platelet activation may promote thrombosis and amplify inflammation, as indicated by previous experimental evidence, and the similarities with atherothrombosis and thrombotic microangiopathies. Antiplatelet agents represent the cornerstone in the prevention and treatment of atherosclerotic arterial thromboembolism, with limited efficacy in the context of venous thromboembolism. The use of acetylsalicylic acid may improve inflammation and respiratory function in humans as indicated by the results of observational studies. There are no validated protocols for thrombosis prevention in Covid-19. There is scientific rationale to consider acetylsalicylic acid for the prevention of thrombosis in the pulmonary circulation and attenuation of inflammation. This is supported by numerous demonstrations of the anti-inflammatory activity of antiplatelet agents and the evidence of improvement in respiratory function both in human and experimental pathology. The hypothesis underlying the present study project is that in Covid-19 platelet activation occurs through an inflammation-dependent mechanism and that early antithrombotic prophylaxis in non-critical patients could reduce the incidence of pulmonary thrombosis and respiratory and multi-organ failure improving clinical outcome in patients with SARS-CoV2 pneumonia. The prevention of thrombogenic platelet activity with acetylsalicylic acid could be superior to fixed dose enoxaparin alone. The proposed treatment is feasible in all coronavirus disease 2019 (COVID-19) patients, regardless of the treatment regimen (antivirals, anti-inflammatory drugs), except for specific contraindications. To this aim, the investigators a randomised, placebo-controlled, double blind, parallel arms study to investigate the potential protection of acetylsalicylic acid towards the progression of lung failure in patients admitted to a medical ward for SARS-CoV-2 pneumonia. A 15-day treatment period is considered. Primary endpoint is the occurrence of one of the following events: admission to an intensive care unit, requirement of mechanical ventilation, PaO2/FiO2 less than 150 mm Hg.