Le Plessis Robinson

This research aims to evaluate the effects of TAK-330 compared to standard four-factor prothrombin complex concentrate 4F-PCC in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. The study focuses on reversing anticoagulation caused by Factor Xa inhibitors and is a Phase 3, randomized, triple-blind trial sponsored by Takeda. Participants will be randomly assigned to receive either TAK-330 or the standard 4F-PCC. TAK-330 is given as a single intravenous infusion dose of 25 IUkg before surgery, with an optional additional 25 IUkg dose during surgery if needed, not exceeding a total of 50 IUkg or 5,000 IU. The standard 4F-PCC dose and infusion speed follow local protocols, with an additional dose allowed during surgery under the same maximum limits. These treatments are administered during hospitalization prior to surgery. During the study, participants will be hospitalized for the surgery and treatment administration, with assessments of hemostasis effectiveness at surgery end and 24 hours after treatment. Researchers will monitor blood product use, adverse events including thrombotic events, and participant survival up to 30 days after surgery. Follow-up will also include contact via telehealth or phone 30 days post-surgery to evaluate safety and outcomes. Total participation duration covers the hospital stay and the 30-day post-surgery monitoring period.

Researchers are evaluating the efficacy and safety of belumosudil compared with placebo in adult participants who have chronic lung allograft dysfunction CLAD after bilateral lung transplantation. This Phase 3, randomized, double-blind, placebo-controlled study focuses on participants at least one year after their transplant, who show progressive CLAD despite treatment with azithromycin. The study is multinational, multicenter, and parallel-group, aiming to assess lung function changes over time. Participants will receive either 200 mg of oral belumosudil once daily or a matching placebo, both alongside azithromycin and standard immunosuppression care. The study includes a treatment period lasting up to 26 weeks for those not entering the open-label extension OLE and up to 52 weeks for those entering the OLE but not the long-term extension. For participants in the long-term OLE, treatment and study visits continue every 12 weeks as specified. During the study, participants will attend up to 10 visits if not entering the OLE, or up to 16 visits if entering the OLE but not the long-term phase. Assessments include lung function tests such as forced expiratory volume in 1 second FEV1 and forced vital capacity FVC, 6-minute walk distance, and quality of life questionnaires. Safety is monitored by recording adverse events. The total study duration may be up to 31 weeks for some and up to 57 weeks for others, with ongoing monitoring for those in the long-term extension.

The Abbott Structural Heart SH Registry is designed to confirm the safety and performance of Abbotts commercially available structural heart devices in real-world clinical settings. It collects data from routine hospital practices and standard-of-care procedures involving patients with various heart conditions such as atrial septal defect, ventricular septal defect, patent foramen ovale, and valvular heart disease. The study aims to meet regulatory requirements, including those from the European Union Medical Device Regulations 2017745, by conducting active post-market clinical follow-up for these devices. Participants in this observational registry receive structural heart devices like the Amplatzer Occlusion Devices for septal defects or the Epic Surgical Tissue Heart Valve devices for valve replacement as part of their standard care. Enrollment occurs either before the procedure or shortly afterward, depending on the device type. Follow-up visits align with routine care schedules and may be in-person, virtual, or by phone. Follow-up duration varies by device, ranging from discharge or 7 days post-procedure up to 10 years to monitor long-term performance and safety. A specific surgical valve sub-study is included to gather data for regulatory approval of certain valve sizes. Participants provide informed consent and are followed through standard care visits where data is collected about safety and effectiveness outcomes. The registry tracks primary safety endpoints at 7 days post-procedure and effectiveness at baseline. Follow-up assessments may include in-office or remote visits and data collection over months to years depending on the device implanted. The total participation duration depends on the device but can extend up to a decade, ensuring long-term monitoring of device performance in everyday clinical practice.

Congenital heart defects CHD are a major cause of birth defects affecting millions worldwide, including about 41,000 newborns annually in Europe. CHD is linked with high rates of illness and death throughout life, and over half of infants with critical CHD develop neurodevelopmental disorders NDDs. These NDDs involve early disruptions in brain development affecting cognitive, emotional, and behavioral functions, often leading to challenges in language, learning, motor skills, and social interactions. The CATAMARAN neonatal cohort project seeks to detect developmental delays as early as six months in infants with CHD and to identify factors that contribute to these delays. The study includes 150 fetuses diagnosed prenatally with critical CHD requiring cardiac surgery within the first three months of life, along with their two parents. Researchers will perform neurodevelopmental assessments using the Bayley-IV test and collect various biological samples at delivery and during hospitalization for surgery. These samples include maternal and infant blood, placenta tissue, and stool for genetic, metabolomic, microbiome, and other analyses. Additional data on pregnancy, obstetric events, fetal ultrasounds, echocardiography, and parental stress levels will also be gathered. Participants will be monitored at six months of age to evaluate the prevalence and specifics of developmental delays. The study will assess how genetic factors, placental anomalies, maternal behaviors, and surgical details relate to these delays. Parents will complete questionnaires about diet and post-traumatic stress. Researchers will collect cardiovascular and developmental follow-up data, postoperative brain MRI scans, and track neonatal microbiota to better understand the origins and impacts of neurodevelopmental disorders in infants with CHD.

Researchers are collecting Real-World Data to better understand treatment outcomes and health economics related to lesions in the peripheral vasculature. This global, prospective, non-randomized, open-label, multi-center Registry aims to include populations not well represented in previous Peripheral Vascular Disease trials. The study supports the safe use of commercially available Boston Scientific drug-eluting devices for this condition. Participants receive treatment using any eligible commercially available Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. The study includes two cohorts a Clinical Cohort, where patients undergo standard of care assessments with follow-up for up to 2 years in multiple countries and 5 years in China, and an Outcomes Cohort at select sites with additional evaluations including Quality of Life questionnaires, six-minute walk tests, and healthcare utilization data collection. During the study, participants complete various assessments according to standard care and additional tests depending on their cohort. Researchers measure major adverse events and lesion patency at 12 months to evaluate outcomes. The study monitors participants through follow-up visits extending up to 5 years to gather safety and effectiveness data in real-world clinical practice.

Researchers are evaluating early fluid removal strategies in Intensive Care Unit ICU patients with acute kidney injury AKI who are receiving renal replacement therapy RRT and have fluid overload. Fluid overload in these patients is linked to increased complications and higher risk of death. The study compares two fluid removal approaches to see if a moderate removal rate guided by tissue blood flow monitoring can improve kidney, heart, and lung outcomes compared to a low removal rate that stabilizes fluid without such monitoring. Participants are randomly assigned to one of two groups. The experimental group will have fluid removed at a rate of 2 ml per kilogram per hour, adjusted based on tolerance and blood flow, aiming to reach their original body weight. If this target is not met within 24 hours, the rate can be increased. The control group will have fluid removal set between 0 and 1 mlkgh to maintain body weight stability, with adjustments as needed. Fluid removal may be paused temporarily if signs of poor blood flow or intolerance occur. During the study, participants will be closely monitored with assessments of organ function, kidney recovery, heart rhythm, and respiratory support needs for up to 30 days. The main measure is the number of days without needing organ support by day 30. Other evaluations include mortality, time off mechanical ventilation and vasopressors, ICU stay length, and complications such as strokes or intestinal ischemia. The trial aims to determine if a guided moderate fluid removal improves overall health outcomes in this critical patient group.

Researchers are investigating the relationship between cannabis use and lung cancer, focusing on patients aged 18 to 59 years treated for primary lung cancer. Cannabis is widely consumed and has recognized neuro-psychic effects, but its impact on lung cancer development remains uncertain. Previous studies suggest cannabis smoke contains more carcinogens than tobacco smoke, and clinical observations have raised concerns about cannabis possibly contributing to more aggressive lung cancers in young patients who are heavy users. The study categorizes participants into three groups cannabis smokers who also use tobacco, tobacco-only smokers, and non-smokers. Participants will provide blood and hair samples to support the research. This study is non-randomized and does not involve blinding. The primary measure is the percentage of patients who are active cannabis smokers, defined as smoking at least 10 joints per month for at least one year. Participants will be monitored for cannabis use status, and researchers will collect biological samples to analyze potential differences in lung cancer profiles across groups. The study aims to understand the prevalence of cannabis smoking among lung cancer patients and its possible influence on disease characteristics. This involvement includes consenting to sample collection and data recording during their treatment period, with the research spanning multiple hospitals.

This research aims to assess the safety and performance of Cooks various custom-made stent-graft devices used for endovascular treatment of complex abdominal aortic aneurysms, thoracoabdominal aortic aneurysms, aortic arch aneurysms, and chronic aortic dissections. The study collects real-world data on the use of these devices to support their ongoing market availability and post-market surveillance as well as further technological development by Cook. Participants will receive treatment using Cooks custom-made endovascular grafts designed for complex aortic diseases. The study is observational and does not involve assigning participants to specific treatment groups but rather monitors patients receiving these devices in usual care settings. During the study, researchers will track treatment success rates at 12 months and safety outcomes within 30 days after treatment. Participants will undergo clinical follow-up visits to monitor outcomes. The study results will contribute to understanding device performance and safety in real-world use. The study will continue until December 2030.

Researchers are collecting real-world data to evaluate the Ion endoluminal system, a device used for biopsies and localization of lung nodules. This observational study is conducted across multiple centers in Europe and aims to observe procedural details and both short- and long-term clinical outcomes following the use of this CE-marked device. Approximately 1,200 patients undergoing elective lung nodule biopsy or localization will be enrolled according to specific eligibility criteria. Participants will undergo lung lesion biopsy andor localization procedures using the Ion endoluminal system as part of their standard care. This is a single-arm, prospective study without randomization or control groups. The study observes the real-world use of the device after its market approval, following patients from the procedure through follow-up periods. During the study, participants will be monitored for diagnostic yield from the procedure through 24 months post-procedure. Researchers will also track safety outcomes such as pneumothorax and bleeding from the procedure through 30 days afterwards. Participants will provide informed consent and be observed according to the protocol without altering their usual treatment. The total study duration extends through 2029, with continued data collection throughout that time.

Researchers are evaluating a faster, simpler, and noninvasive method to assess fluid responsiveness in critically ill children with circulatory failure. The study aims to validate a test based on the effects of a standardized abdominal compression measured by electrical cardiometry, to help doctors identify which patients might benefit from fluid expansion and avoid harmful fluid overload. This observational, multi-center study focuses on children prescribed a 10 mlkg volume expansion for circulatory failure in pediatric intensive care units. The study involves performing a standardized abdominal compression maneuver using a sphygmomanometer inflated with 80 ml of air, applying gentle pressure on the patients abdomen. Stroke volume variation induced by this maneuver is measured continuously with electrical cardiometry, a noninvasive cardiac output monitor. Echocardiography assessments are conducted before and within one hour after fluid expansion to measure stroke volume changes as the gold standard for fluid responsiveness. No additional blood tests or invasive procedures are performed. Participants will undergo echocardiographic and electrical cardiometry evaluations around the time of their prescribed fluid expansion, with monitoring continuing until discharge from the pediatric intensive care unit or up to 28 days. Researchers will analyze the diagnostic accuracy of the abdominal compression test in predicting a 15% or greater increase in stroke volume after fluid expansion. The main outcome measure is the area under the ROC curve for stroke volume variation induced by abdominal compression compared to echocardiographic results.