Blood Clot (Thrombosis)

Deep vein thrombosis (DVT) and its fatal complication pulmonary embolism (PE) afflict millions of people worldwide and are responsible for a large percentage of acute hospitalizations. Clinical assessment of DVT is notoriously unreliable because up to 2/3 of DVT episodes are clinically silent and patients are symptom free even when PE has developed. Symptomatic DVT events, that are eventually referred for ultrasound imaging are only the tip of the DVT iceberg. The subgroup of events that evolve to develop clinical indications cannot be accurately predicted and often lead to sudden death from PE regarded as "the leading cause of preventable death in hospitalized patients" and "the number one priority for improving patient safety in hospitals". Deep vein thrombosis (DVT) is the formation of a blood clot within the deep veins, most commonly those of the lower limbs, causing obstruction of blood flow. In 50% of people with DVT, the clot is at some point detached from the vein wall and travels to the lung to cause pulmonary embolism. About 25% of people experiencing pulmonary embolism (PE) will die from it, making it the 3rd leading cause of cardiovascular death worldwide after stroke and heart attack. Even in patients who do not get PE, recurrent thrombosis and "post-thrombotic syndrome" are major causes of mortality and reduced quality of life. Recent European population studies report DVT incidence of 70-140 cases/100,000 person-year, which translates to roughly 522,000 to 1.04 million cases per year in Europe. Respectively, Center for Disease Control and Prevention (CDC) reports around 900,000 DVT incidents per year in USA, with an estimate of 60,000-100,000 related deaths per year. Venous thromboembolism (that collectively defines DVT and/or PE) during hospitalization is the leading cause of disability-adjusted life-years (DALYs) lost in low- and middle-income countries, and the second most common cause in high-income countries, causing loss of more DALYs than nosocomial pneumonia, catheter-related bloodstream infections, and adverse drug events. No identifiable provoking risk factor is reported in about 25%-40% of DVT and pulmonary embolism incidents. Surgery is reported to account for 15% of the cases and especially orthopaedic surgery with postoperative rates of around 1% reported despite pharmacological thromboprophylaxis; immobilization is reported to account for 15% and cancer for about 20% of cases. Early diagnosis of DVT is crucial and has been proven to prevent life-threatening complications (pulmonary embolism), minimize the risk of long-term disability (post-thrombotic syndrome, recurrent DVT), improve treatment outcomes, and reduce healthcare costs. Despite the progress made in ultrasound imaging and plethysmography techniques, there is a need for new methods to enable continuous monitoring DVT diagnosis in hospitalized and other high-risk patients at the point of care. ThrombUS+ EU Horizon project brings together an interdisciplinary team of industrial, technology, regulatory, social science and clinical trial experts to develop a novel wearable device for operator free, continuous monitoring in patients with high DVT risk. The devices and software to be developed during this project are expected to achieve automated early DVT detection, provide a continuous assessment of DVT risk and support DVT prevention via extended reality and serious gaming. ThrombUS+ wearable is intended for use by postoperative patients in the ward, during long surgical operations, cancer patients or otherwise bedridden patients at home or in care units, and women during pregnancy and postpartum. ThrombUS+ will use big data sets for artificial intelligence (AI) training collected in the project via 3 large scale clinical studies and will validate the outcome in the clinical setting via 1 early feasibility study and 1 multi-center clinical trial. This study (ThrombUS\_Study\_A) aims to collect and create a labelled ultrasound image data set containing ultrasound images series of patients that undergo routine ultrasound scans on lower limbs, because of suspected deep vein thrombosis. The data will be used to train AI models within ThrombUS+ project to achieve automated detection of deep vein thrombosis on conventional ultrasound scans. The data set will include negative scans, positive for deep vein thrombosis scans, positive for other diagnosis scans and scans of insufficient quality to aid towards diagnosis, together with imaging metadata and a set of labels for each scan. In addition, the dataset will include pseudonymized patient demographics, referral note, existing known medical conditions at the time of scan, diagnosis based on the scan, operator anonymized ID, and metadata on the ultrasound equipment and scanning protocol parameters. The data set will be completely anonymized to be used for research purposes, in compliance with the General Data Protection Regulation (GDPR) and the European Health Data Space (EHDS) and the upcoming Artificial Intelligence Act (AIA). Furthermore, the anonymized data set will be described in the Argos/OpenAIRE tool and will be made available through the European Open Science Cloud (EOSC) portal via OpenAIRE, to be used by other researchers for image processing, analysis, and AI model training. This is a non-interventional diagnostic image data collection study.

The standard or usual treatment for a superficial vein thrombosis (SVT) is to treat with a low-dose (often called a prophylactic dose) of blood thinner for 45 days. Rivaroxaban is a type of oral blood thinner that is used in the treatment and prevention of blood clots. Currently, rivaroxaban 10mg daily for 45 days is the most commonly used treatment in patients with lower extremity SVT. Recent studies of participants with SVT suggest that treatment with full-dose (sometimes called therapeutic dose) blood thinners could be promising in preventing additional complications from SVT such as: * A new blood clot in the deep veins of the legs or arms * A new pulmonary embolism (a blood clot in the lungs) * A recurrence or extension of the existing SVT (the existing clot comes back after treatment is stopped or gets bigger) The Investigators are studying whether a full-dose of rivaroxaban for 90 days could prevent or improve additional complications from SVT.

This clinical investigation is a prospective, single-arm, multicenter, post-market study to proactively collect clinical data on the LeMaitre® TufTex Over-the-Wire (OTW) Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. The intended purpose of the device in this post market clinical study is identical to the indication of use of the device. The TufTex OTW post-market study is initiated by the Sponsor and manufacturer of the device, LeMaitre Vascular, Inc. The investigation will take place in 4 sites, most likely in 3 different countries. A total number of 112 subjects is anticipated to be enrolled, who are intended to undergo surgical treatment for the removal of a emboli and/or thrombi. The anticipated enrollment period is 48 months, and the participation per subject is 1 month. The total study duration is expected to be 56 months (4 months start-up, 48 months of recruitment, 1 month of follow-up, 3 months of closure.

This prospective, single arm, post market clinical study was designed to proactively collect clinical data on the LeMaitre® TufTex Single Lumen Embolectomy Catheters and to confirm its performance in removing arterial emboli and/or thrombi, to identify and analyze emergent risks on the basis of factual evidence, and to ensure the continued acceptability of the benefit/risk ratio. This post market study is sponsored by LeMaitre® Vascular, Inc., the manufacturer of the device. Study will take place at 3 to 8 sites in Europe, the target sample size is 112 patients.

This study collected clinical, laboratory, and CT parameters of acute patients with acute pulmonary embolism from admission. The outcomes of interest were defined as the occurrence of adverse outcomes within 30 days after admission into hospital. Eligible patients were randomized in some ratio into derivation and validation cohorts. The derivation cohort was used to develop and evaluate a multivariable logistic regression model for predicting the outcomes of interest. The discriminatory power was evaluated by comparing the nomogram to the established risk stratification systems. The consistency of the nomogram was evaluated using the validation cohort.

This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency. The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662). During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.

The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.

The goal of this clinical trial is to learn if troxerutin works to prevent thrombotic events in mild or severe COVID-19 patients. It will also learn about the safety of troxerutin. The main questions it aims to answer are: * Does troxerutin lower the number of thrombotic events in participants? * What medical problems do participants have when taking troxerutin? Researchers will compare troxerutin to a placebo (a look-alike substance that contains no drug) to see if troxerutin works to prevent thrombotic events in COVID-19 patients. Participants will: * Take troxerutin or a placebo every day for 7 days. * Visit the clinic at the first, fourth, seventh and 28th days after enrollment for checkups and tests * Keep a diary of their symptoms and the number of times of thrombotic events, bleeding events and type II HIT-related thrombocytopenia

This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA. While the identity of the study drug will be unblinded, the specific dose of SRSD107 will be blinded. Up to approximately 450 subjects will be randomized.

The goal of this clinical trial is to evaluate the safety, tolerability, and recommended Phase 2 Dose (RP2D) of KLN-1010 in patients with relapsed or refractory multiple myeloma.