Blood Clot (Thrombosis)

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.

This clinical trial evaluates the LeMaitre4 TufTex Single Lumen Embolectomy Catheter in patients undergoing surgery to remove arterial emboli and thrombi. The study aims to confirm the device's performance and safety, identify any new risks based on real patient data, and ensure the benefit-risk balance remains acceptable. Sponsored by LeMaitre4 Vascular, Inc., the study is conducted at several sites in Europe with a planned enrollment of 112 patients. Participants will receive treatment using the LeMaitre4 TufTex Single Lumen Embolectomy Catheter, a device featuring a latex balloon attached to a radiopaque shaft. The balloon helps remove emboli and thrombi by being withdrawn through an artery during surgery. This is a single-arm study, meaning all participants receive the device treatment without comparison groups. During the study, researchers will monitor safety outcomes such as device- or procedure-related serious events during and up to one month after the procedure. They will also assess technical success based on the amount of artery narrowing after one month. Additional evaluations include clinical success, revision rates, and artery openness over time. Participants will be followed for at least one month after treatment to track these outcomes and ensure safety.

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 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 evaluating whether troxerutin can help prevent blood clots in adults with mild or severe COVID-19. This Phase 1 clinical trial aims to compare troxerutin with a placebo to see if it reduces thrombotic events and to assess the safety of troxerutin in this patient group. The study addresses key questions about how often blood clots occur and what side effects may happen during treatment. Participants will receive either oral troxerutin tablets or matching placebo tablets twice daily for 7 days. Some groups will also receive low molecular weight heparin once daily. The study includes four visits to the clinic on days 1, 4, 7, and 28 for checkups and tests. Participants will keep a diary tracking symptoms, blood clot events, bleeding events, and a specific blood platelet condition related to heparin. During the study, researchers will monitor participants' health through clinical assessments and laboratory tests to measure the number of patients in a prothrombotic state over 7 days. Safety will be evaluated by recording any adverse events through 28 days. The total involvement includes treatment and follow-up visits over about four weeks, ensuring close observation of participants' responses and any side effects.

Researchers are evaluating the efficacy and safety of three different dose levels of SRSD107 compared to enoxaparin 40 mg daily in adults aged 60 to 80 undergoing elective primary unilateral total knee arthroplasty (TKA). This Phase 2, multicenter, randomized, open-label study includes a blinded endpoint evaluation and aims to find the best dose of SRSD107 for preventing venous thromboembolism (VTE) after surgery. Participants will be assigned to one of four groups: low, medium, or high single subcutaneous doses of SRSD107, or enoxaparin 40 mg subcutaneously once daily for 12 ±2 days after surgery. The identity of the study drug is known, but the specific SRSD107 dose is blinded. Up to approximately 450 subjects will be randomized to these groups. During the study, participants will take the study drug at least 28 days before surgery and attend clinic visits, including venography 10 to 14 days after TKA. Researchers will monitor the incidence of total VTE events from surgery through 12 ±2 days post-surgery as the primary outcome. Secondary outcomes include major VTE, bleeding events, and adverse events up to Day 169. Safety and efficacy assessments will continue throughout the study period, which ends in October 2026.

Researchers are evaluating KLN-1010, a novel gene therapy, in patients with relapsed or refractory multiple myeloma to assess its safety, tolerability, and to determine the recommended Phase 2 dose. The trial is a Phase 1 study sponsored by Kelonia Therapeutics, Inc., focusing on patients who have previously undergone multiple treatments for their condition. Participants receive a single specified dose of KLN-1010, which is designed to generate anti-B Cell Maturation Antigen (anti-BCMA) CAR-T cells in the body. This gene therapy is administered once during the study, and its effects, including safety and pharmacokinetics, are closely monitored over time. During the study, participants undergo assessments for treatment-emergent adverse events and dose-limiting toxicities for up to 15 years after dosing. Pharmacokinetic evaluations of KLN-1010 and generated CAR-T cells occur up to two years post-infusion. Multiple myeloma status is monitored from dosing until disease progression or up to 15 years, with comprehensive safety and disease assessments throughout the follow-up period.