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.

This NIH-sponsored study aims to characterize three biomarkers derived from 129Xe gas exchange MRI and understand how they change in response to interventions. The study focuses on markers derived from the interaction of 129Xe with pulmonary capillary red blood cells RBCs, specifically RBC transfer MRI, cardiogenic oscillations in 129Xe-RBC signal amplitude, and the 129Xe-RBC chemical shift. The study population includes healthy volunteers, patients scheduled to undergo transfusion or phlebotomy, patients with dyspnea, interstitial lung disease ILD, idiopathic pulmonary fibrosis IPF, non-specific interstitial pneumonias NSIP, chronic hypersensitivity pneumonitis cHP, sarcoid, chronic thromboembolic pulmonary hypertension CTEPH, and acute pulmonary embolism.

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 participants 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 devices 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 models 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 tools performance and safety throughout the monitoring period.

This research aims to gather real-world data on the clinical outcomes of the EkoSonicTM Endovascular System in Chinese adults diagnosed with acute pulmonary embolism. The study focuses on patients who have symptoms lasting less than 14 days and a specific heart measurement indicating right ventricular strain. This observational study will include up to 30 participants receiving this treatment during their standard clinical care. Participants will be treated with the EkoSonicTM Endovascular System, which is a non-implanted device consisting of a single-use infusion catheter with an ultrasonic core and a reusable control system. The device is used alongside a medication called r-tPA to treat the pulmonary embolism. The study observes these treatments as they are given in routine care without randomization or comparison groups. During the study, participants will have various assessments including echocardiographic measurements of the right and left ventricles at baseline, 24 and 48 hours after treatment, at discharge, and during follow-ups at 1, 3, and 6 months, continuing on average for one year. Researchers will also monitor pulmonary embolism events and serious adverse events related to the device or procedure. Participants will be followed for safety and efficacy outcomes throughout the study 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 studying the use of Freeze-dried Human Protein C Concentrate TAK-662 for treating people with congenital protein C deficiency in Japan. The main goal is to assess adverse events and effectiveness of TAK-662 in managing this condition. This observational study records how TAK-662 is used under routine medical practice without involvement from the study sponsor. Participants will receive TAK-662 through intravenous injection during their usual care. The study observes participants receiving TAK-662 for an initial period of up to 12 months to evaluate adverse events. For those who continue with long-term supplementation after acute or short-term treatment, monitoring may extend up to 24 months to collect additional safety data. During the study, researchers will document adverse events including treatment-emergent effects and specific concerns like venous thromboembolism and purpura fulminans. Participants will be monitored regularly as part of their routine care, with safety and effectiveness tracked up to 24 months depending on treatment duration. The total participation time varies depending on the length of TAK-662 supplementation.

This research aims to develop and evaluate a unique home-based exercise program for people who have had pulmonary embolism, using expertise from cardiovascular specialists and cardiac physiologists with an Interactive Care Plan. The study focuses on improving mobility outcomes in adults who experienced intermediate- or high-risk acute pulmonary embolism. It is a pilot feasibility trial designed to assess the practical delivery and impact of this intervention. Participants will be randomly assigned to either a home-based exercise training group or a standard therapy group without intervention. Those in the exercise group are recommended to exercise three times a week for 20 minutes per session over 12 weeks, with personalized plans developed through consultation with a clinical exercise physiologist. The study measures changes in physical capacity and quality of life over 6 months. During the study, participants will be assessed at baseline, 3 months, and 6 months for physical capacity, pulmonary embolism-specific quality of life, general quality of life, and daily steps. Follow-up visits include questionnaires and physical evaluations to monitor progress. The total duration of participation is up to 6 months, with the primary focus on changes in physical capacity from baseline.