Venous Thromboembolism (VTE)

Researchers are evaluating treatments for patients with high-risk pulmonary embolism (PE), a serious condition that requires immediate clot removal in addition to blood thinners. This trial compares two approaches: catheter-directed thrombectomy (CDT), a procedure that directly removes clots using a device, versus standard full-dose systemic thrombolysis, which dissolves clots using medication. The study aims to see if CDT can reduce death rates and serious complications better than the usual treatment, while also improving recovery and quality of life over one year. Participants are randomly assigned to one of two groups. One group receives the CDT procedure, where a catheter is guided through veins to the lungs to extract clots using suction, combined with blood thinners during the procedure. The other group receives full-dose systemic thrombolysis using clot-dissolving drugs such as Alteplase, Urokinase, or Tenecteplase. The study is open-label, meaning both patients and doctors know which treatment is given. Researchers will monitor effects at various points, including day 7, day 30, and up to one year after treatment. During the trial, participants undergo evaluations including clinical and hemodynamic assessments to determine treatment success, monitoring of oxygen levels, length of stay in intensive care and hospital, and quality of life questionnaires over a year. The main measure is a combined rate of death, treatment failure, major bleeding, and stroke at 30 days. Secondary outcomes include survival, bleeding events, oxygen use, and long-term functional recovery. Cost-effectiveness of the treatments will also be analyzed after one year.

Researchers are studying biomarkers from 129Xe gas exchange MRI to understand how they change with different medical interventions. The study focuses on interactions between 129Xe and red blood cells in the lungs. Participants include healthy volunteers and patients with conditions like interstitial lung disease, pulmonary hypertension, acute or chronic pulmonary embolism, anemia, polycythemia, and dyspnea. The study uses hyperpolarized xenon gas inhaled in multiple doses followed by breath holds, alongside oxygen administration. Participants are grouped by treatment: those undergoing transfusion or phlebotomy, patients receiving oxygen for lung-related conditions or healthy volunteers, and those recently diagnosed with acute or chronic pulmonary embolism. Treatments and responses are monitored at baseline and various follow-up points. Participants will undergo MRI scans to measure red blood cell transfer, chemical shifts after oxygen delivery, and changes in red blood cell signal oscillations before and after treatment. The study includes visits up to 3–6 months after interventions to track changes. Researchers also monitor safety and participant adherence throughout the study, which lasts until mid-2028.

Researchers are collecting and creating a labeled ultrasound image data set from patients undergoing routine ultrasound scans of their lower limbs due to suspected deep vein thrombosis (DVT). This observational study aims to gather imaging data, patient information, and ultrasound metadata to train artificial intelligence (AI) models that can automatically detect DVT from conventional ultrasound scans. The study is part of the ThrombUS+ project, which focuses on developing tools for early and automated DVT diagnosis to improve patient safety and outcomes. The study involves selecting patients suspected of having DVT who are referred for ultrasound scans. These patients, both inpatients and outpatients, will be consecutively included to ensure diversity of demographics, medical conditions, and ultrasound operators. The collected data will include ultrasound image series and video clips, along with anonymized patient demographics, referral notes, medical conditions, scan diagnoses, operator IDs, and ultrasound equipment details. The anonymized data set will be prepared according to regulations for research use and shared publicly through European science portals. Participants will undergo routine ultrasound scans for suspected DVT, and their scan data and related information will be collected and anonymized. The primary outcome is the ultrasound data collected on the day of the scan. The data set will support AI model training and research, with the anonymized information made available for further study. Participation involves providing informed consent and allowing the inclusion of their scan data and metadata. The study will monitor data quality and maintain privacy throughout, with no interventional treatments involved.

Researchers are evaluating the use of rivaroxaban, a blood thinner, in adults with superficial vein thrombosis (SVT) of the leg. This pilot study aims to test the study plan and see if enough participants will join a larger trial. It includes a small group and is not designed to prove safety or effectiveness, but to measure recruitment rates over 12 months. Participants will be randomly assigned to one of two groups. One group receives full-dose rivaroxaban for 90 days, starting with 15mg twice daily for 21 days, then 20mg once daily for 69 days. The other group receives a lower dose of rivaroxaban for 45 days combined with placebo pills to keep the study blinded, followed by 45 days of placebo alone. During the study, participants will be monitored to see how many join each month and how well the study procedures work. Researchers will track outcomes over 12 months, including recruitment feasibility and secondary measures from the start of recruitment until the last participant's follow-up. The study uses a randomized, double-blind design to evaluate these aspects.

This clinical investigation is a prospective, single-arm, multicenter post-market study designed to collect clinical data on the LeMaitre TufTex Over-the-Wire (OTW) Embolectomy Catheters. The study aims to confirm the device's performance in removing arterial emboli and thrombi, identify any emerging risks based on factual evidence, and ensure the continued acceptability of its benefit-to-risk ratio. The device is used for patients undergoing surgical treatment for emboli or thrombi removal, with the study sponsored by LeMaitre Vascular, Inc. The study involves using the LeMaitre TufTex OTW Embolectomy Catheter, which is intended for removing emboli and thrombi during embolectomy or thrombectomy. The catheter can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion, and aspiration. The investigation is planned to enroll 112 subjects across four sites in about three countries, with an enrollment period lasting 48 months. Each participant will be followed for one month after the procedure. The total study duration is approximately 56 months, including start-up, recruitment, follow-up, and closure phases. Participants will undergo surgical treatment using the catheter, and researchers will assess technical success defined as less than 30% residual stenosis one month after the procedure. Safety will be monitored during the procedure and follow-up. Additional outcomes measured include clinical success, revision rates, and vessel patency at one month post-procedure. The study includes monitoring for any adverse events to ensure safety and performance. Participation involves one month of follow-up after the surgical procedure to evaluate these outcomes.

Researchers are studying acute pulmonary embolism, a condition where blood clots block lung arteries, to predict possible serious outcomes within 30 days after hospital admission. This observational study collects clinical, laboratory, and CT scan data from patients diagnosed with acute pulmonary embolism. The goal is to develop a predictive tool using these data to identify patients at higher risk of adverse events. Patients diagnosed with pulmonary embolism by CT pulmonary angiography and aged 18 or older are included. Participants are divided into two groups: one to create and assess a prediction model using logistic regression, and the other to validate this model. The model's accuracy is compared to existing risk assessment systems, aiming to improve early identification of patients who may experience complications. During the study, clinical and imaging data, including CT scans and laboratory tests like cardiac troponin I and NT-pro BNP levels, are collected from admission. Researchers monitor outcomes over 7 and 30 days to evaluate the occurrence of adverse events. The study tracks participants' health status to assess the prediction tool's performance and safety throughout the monitoring period.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of CITY-FXI, a drug targeting Factor XI, in healthy adults and adults with Factor V Leiden (FVL) or prothrombin G20210A mutation. This first-in-human, randomized, double-blind, placebo-controlled study aims to better understand how CITY-FXI works in these populations and its potential effects. The trial is sponsored by City Therapeutics and includes participants aged 18 to 60 years. The study consists of two parts: Part A involves single ascending doses of CITY-FXI or placebo given by subcutaneous injection to healthy adults, and Part B includes similar dosing in adults diagnosed with FVL or prothrombin G20210A mutation. Women of childbearing potential in Part B must use highly effective contraception. The doses will be increased in a controlled manner to assess safety and drug behavior. Participants will be monitored for adverse events throughout the study, up to 360 days after dosing. Researchers will measure drug levels in the blood and urine shortly after dosing, and track changes in blood clotting factors and activity over time. Study visits will include physical exams, laboratory tests, and safety assessments to evaluate treatment effects and participant well-being over the follow-up period.

Researchers are conducting a study in Japan to observe the use of Freeze-dried Human Protein C Concentrate (TAK-662) in people with congenital protein C deficiency. The main goal is to monitor the occurrence of side effects and assess how this treatment performs in managing the condition. The study is observational and focuses on real-world use without altering routine medical practices. Participants will receive TAK-662 through intravenous injection as part of their standard care. The study records the administration of TAK-662 and observes participants for adverse events over 12 months. For those needing long-term supplementation after initial or short-term treatment, monitoring may extend up to 24 months. The study sponsor does not influence treatment decisions but collects data on treatment effects and safety. During the study, participants will be regularly evaluated for any treatment-emergent adverse events, including specific complications such as venous thromboembolism and purpura fulminans. The research team collects information throughout the follow-up period to understand the safety profile of TAK-662. Participants' health and any side effects are closely monitored to provide comprehensive safety data over the study duration.

Researchers are evaluating a new way to deliver home-based exercise for people who have had a pulmonary embolism, a condition where blood clots block blood flow in the lungs. This study aims to use the combined expertise of heart specialists and exercise physiologists to create an interactive care plan that supports patients in their recovery. The trial is a pilot feasibility randomized study that focuses on improving mobility outcomes in this patient group. Participants will be randomly assigned to either a home-based exercise training group or a standard therapy group. Those in the exercise group are recommended to exercise three times a week for 20 minutes per session over 12 weeks. The exercise program is personalized based on a consultation with a clinical exercise physiologist. The standard therapy group will receive usual care without the added exercise intervention. During the study, participants will have their physical capacity assessed at the start, 3 months, and 6 months. Researchers will also track changes in quality of life specific to pulmonary embolism and general health, as well as the number of steps taken by each participant over time. Follow-up visits at baseline, 3 months, and 6 months will help monitor progress and collect the necessary data. The total study duration extends up to 6 months for each participant.

Researchers are studying the connection between portal vein thrombosis (PVT) and outcomes after liver transplantation. The study aims to find out how common PVT is, what risk factors contribute to it, and how having PVT before surgery affects the prognosis of liver transplant patients. The goal also includes developing a new grading or rating system for PVT to improve clinical care. Participants are grouped into those with PVT and those without PVT before their liver transplant. The study does not involve any treatment or intervention but observes and compares data from both groups. Medical imaging, surgical details, pathology reports, treatments after surgery, and follow-up information will be collected and analyzed to understand PVT’s impact. During the study, researchers will gather demographic and laboratory data, imaging results, and clinical outcomes over time. The main outcomes measured include death, postoperative PVT, and portal vein narrowing over a 10-year period, along with complications within 1 year after surgery. The study monitors participants through their clinical records to build predictive models and clarify how PVT influences transplant prognosis.