Active clinical trials for "Thrombosis"

The study is aimed at assessing the role of the activity of high-risk markers of thrombotic events (MCP-1, MIP1α, IP-10, phosphatedylserine, calreticulin) on the development of thrombotic complications in patients with COVID -19.

Portal vein thrombosis is defined as partial or complete occlusion of the portal vein lumen by the blood clot or its replacement by multiple collateral vessels with the hepato-petal flow, known as 'portal cavernoma'. [1,2] Based on the published literature, 15-25% of patients with cirrhosis have portal vein thrombosis (PVT) [3], and 35-50% of patients with hepatocellular carcinoma (HCC) have malignant PVT [4] compared to 1-3.8 per 100,000 patients in the general population. [5] The reported cumulative incidence of PVT in patients of Child-Pugh A and B is 4.6% and 10.7% at 1 and 5 years respectively with higher incidence among those with decompensated disease or with an underlying hypercoagulable disorder. [6]. Similarly, the prevalence of PVT in compensated cirrhosis is around 1% which increases to 8 - 25% in liver transplant (LT) candidates and 40% in patients with hepatocellular carcinoma (HCC) [7,8]. Based on the published literature 7-9 % of all chronic liver disease patients have hepatic vein outflow tract obstruction (HVOTO) in the Indian population. [9] HVOTO is defined as obstruction to hepatic venous outflow at any site from the right atrium inlet to the small hepatic venules. The Budd-Chiari syndrome (BCS) results from occlusion of one or more hepatic veins (HV) and/or the inferior vena cava (IVC). In the West, the most common cause is HV occlusion by thrombosis. More recent Indian studies have however shown that isolated HV and combined IVC+HV obstruction are now more common. [10] In the post COVID-19 era, there has been great interest in the prothrombotic states associated with the SARS-Cov-2 virus infection, and the adverse effects of some vaccines. [11] With the availability of better molecular tests for hypercoagulable states, use of global coagulation tests (GCT) like rotational thromboelastometry (ROTEM), thromboelastography (TEG) and Sonoclot, use of therapeutic procedures like Transjugular intrahepatic portosystemic shunt (TIPS), availability of novel oral anticoagulants (NOAC), the natural course of disease can be changed with good outcomes. [12] Standard Coagulation tests (SCTs) like PT, aPTT, and platelet count are not predictive of bleeding or coagulation risk as they exclude the cellular elements of hemostasis and are unable to assess the effect of thrombomodulin and cannot assess the stage of the coagulation pathway which is affected. Global coagulation tests provide dynamic information on the coagulation pathway that is not available from conventional tests. [13]

To observe the effectiveness and safety of different therapies-non-vitamin K antagonist oral anticoagulants (NOACs) or vitamin K antagonists (VKAs) or antiplatelet agents and non-antithrombotic therapy - for the treatment of VT.

The aim of this study is to observe the efficacy and safety of lenvatinib in preventing recurrence of hepatocellular carcinoma patients with portal vein tumor thrombus after liver transplantation.

For patients with large head and neck tumors the recommended treatment, in many cases, is a combination of extensive surgery and postoperative radiotherapy. The surgical procedure involves resection of the tumor and reconstruction with a so called microvascular free flap, i.e. tissue transferred from for instance the arm or leg to the resection site. Complications of this complex procedure include, but are not limited to, bleeding and blood cloths (thrombosis) in the transferred tissue (free flap), which can cause very serious complications including need for further surgery and loss of the flap. Routine blood tests can measure parts of the system that regulates bleeding and the forming of blood clots, the so called coagulation system, but these tests don't cover the whole system. There are however more advanced instruments, such as ROTEM, rotational thromboelastometry, which provide a more global view of the hemostatic potential of whole blood. ROTEM is one of few more advanced assays that can be analyzed in emergency situations in major hospitals. Other more advanced coagulation assays are thrombin generation and measurements of specific coagulation factors, several of which are vitamin K dependent. Vitamin K is essential in the coagulation system and also involved in many other physiological processes. Deficiency of this vitamin is common, but not well studied in patients undergoing head an neck free flap surgery. The investigators plan to study ROTEM and other above mentioned coagulation parameters in patients undergoing major head and neck surgery including microvascular free flap reconstruction to assess if these parameters can help predict patients at risk for bleeding or flap thrombosis. Further on this could hopefully enable prevention of complications and improve treatment of coagulation complications that still occur.

The study will evaluate the effectiveness of a novel, real-time risk prediction model for identifying pediatric patients at risk for developing in-hospital blood clots (or venous thromboembolism [VTE]) based on data easily extracted from the electronic medical record. The study will assess whether using the risk percentages for developing VTE derived from the model increases the number of high-risk patients screened by the pediatric hematology team, which may may lead to an overall reduction in the number of pediatric VTEs seen at Monroe Carell Jr. Children's Hospital at Vanderbilt.

This is a randomized, double-blinded, controlled, phase II study. The purpose is to evaluate efficacy and safety of the combination therapy of HAIC (Hepatic arterial infusion chemotherapy) with HLX10 (PD-1 antibody) and HLX04 (VEGF antibody) compared with HAIC and placebo in patients with hepatocellular carcinoma with major portal vein tumor thrombosis.

Left ventricular thrombus is a recognised complication of acute myocardial infarction, associated with stroke, recurrent myocardial infarction and adverse cardiac remodelling. The prevention, treatment and resolution of thrombus is hampered by a lack of understanding of its initiation, propagation and dissolution. Advanced non-invasive imaging holds major promise in improving our understanding of the incidence and the natural history of left ventricular thrombus as well as providing potential biomarkers to assess disease activity and treatment efficacy. In this prospective observational study, the investigators will recruit patients with recent acute anterior myocardial infarction and screen them for evidence of left ventricular thrombus and subclinical stroke using hybrid positron emission tomography and magnetic resonance imaging (PET/MR). Each patient will undergo PET/MR of the heart and head 7±2 days after acute myocardial infarction. If left ventricular thrombus is present on baseline MR, patients will be started on anticoagulation at the discretion of the attending physician, who will determine the agent used (warfarin or direct oral anticoagulant) and the duration of therapy (3-6 months). Patients will then undergo repeat PET/MR at completion of anti-coagulant therapy and then again after another 3 months. Patients with increased 18F- GP1 activity but no overt thrombus on MR will undergo repeat PET/MR of the head and heart at 3 and 6 months to establish the natural history of this observation and its association with thromboembolism in the brain. They will not routinely receive anticoagulation given the exploratory nature of this study.

The treatment strategies for HCC with PVTT is still controversial, and differ substantially between the west and the east. According to western guidelines, including those of the EASL, BCLC, and AASLD, PVTT is regarded as a contra-indication to initial surgery or transarterial chemoembolization. At present, there is still no consensus on the diagnosis and treatment standards of HCC with HVTT/IVCTT. European and American guidelines for liver cancer use The Barcelona Clinic Liver Cancer (BCLC) staging as the standard and classify liver cancer with HVTT/IVCTT into the advanced stage. Molecular targeted drugs such as sorafenib and lenvatinib are recommended to the patients in this phase as first-line treatment drugs and methods. In this regard, experts in China and Southeast Asian countries still have different opinions. They believe that surgery, transarterial chemoembolization (TACE), radiotherapy, and combined treatment with multiple treatment methods can achieve more satisfactory results. HCC with VTT consists of heterogeneous populations with different disease behaviors and prognoses. As a result of recent concept evolution and advances in surgical techniques and perioperative management, emerging evidence shows that selected patients with PVTT may benefit from more aggressive treatment modalities, which are recommended for by Chinese, Japanese, South Korean, and Asia Pacific clinical practice guidelines. A national survey from Japan showed median overall survival with liver resection treatment to be 1.77 years longer than with nonresection therapies, which included TACE, radiotherapy, sorafenib, or conservative treatment (2.87 years vs 1.10 years, respectively; p<0.001). After propensity-score matching of patient baseline characteristics, median overall survival since diagnosis in the liver resection group was 0.88 years longer than in the non-resection group. In a large-scale, multicentre, propensity-score matched analysis from China, surgery was the best treatment for patients with Cheng's type I and II PVTT with Child-Pugh A and selected B liver function. Median overall survival after liver resection (745 of 1580 patients) was 15.9 months (95% CI 13.3-18.5 months) for Cheng's type I PVTT and 12.5 months (10.7-14.3 months) for Cheng's type II PVTT. Thus, aggressive surgical resection in selected patients with HCC with vascular invasion, as proposed by several tertiary health-care centers in the east, seems to be reasonable. Currently, there are no dedicated clinical trials to study the value of hepatic resection in this population. Furthermore, cumulative evidence indicates that long-term overall survival after hepatic resection alone remains unsatisfactory because of the high rate of tumor recurrence and correspondingly low rate of disease-free survival. The combination of perioperative therapies may be more efficacious to improve the prognosis in selected population. More high-level evidence of novel multimodality treatment should be generated. This trial will enroll HCC patients with PVTT CNLC Stage IIIa, who have no prior anti-cancer treatment. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of more aggressive and novel therapeutic candidates in the initial treatment setting. The benefit risk profile for hepatic resection combined with perioperative atezo/bev in this patient population is expected to be favorable.

The RESOLVE-DVT study is a randomized single-center pilot study to determine the effects of hydroxyethylrutoside (Venoruton) on aspects of deep vein thrombosis (DVT) resolution associated with post-thrombotic syndrome (PTS). Based on these results, the investigators will estimate its potential as a preventive therapy for PTS. Eligible consenting patients who develop an acute, objectively confirmed DVT will be randomized and equally allocated to two trial arms, either the treatment group (Venoruton tablet 500 mg twice daily) or the control group (usual care). The pilot trial consists of 5 study contacts over 12 weeks at which outcome assessment is performed: inclusion, 1 week, 4 weeks, 8 weeks, 12 weeks. Treatment allocation is masked for outcome assessors, but not for patients.