Le Plessis Robinson

Researchers are evaluating the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment for reversing anticoagulation in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. This Phase 3 trial aims to assess the safety and effectiveness of TAK-330 in managing direct oral Factor Xa inhibitor-related coagulopathy in this urgent setting. Participants will be randomly assigned to receive either TAK-330 or the standard care 4F-PCC before their surgery. TAK-330 is given as a single intravenous infusion of 25 IU/kg on Day 1, with a possible additional dose if needed. The standard 4F-PCC dosing and infusion speed follow local protocols, with an option for an extra dose not exceeding 50 IU/kg or 5,000 IU during surgery if required. During the study, participants will be hospitalized for surgery and monitored closely. Researchers will assess the effectiveness of stopping bleeding during surgery and follow up with participants by telehealth or phone call 30 days after surgery. The study will track safety and hemostasis to understand the impact of the treatments on bleeding control and patient outcomes.

Researchers are evaluating the effectiveness and safety of belumosudil tablets compared to a placebo in adults who are at least one year past bilateral lung transplantation and have progressive chronic lung allograft dysfunction (CLAD) despite ongoing azithromycin treatment. This Phase 3, multinational, double-blind, randomized, placebo-controlled study focuses on male and female participants aged 18 years or older with evidence of CLAD. The study aims to monitor lung function changes, particularly forced expiratory volume in 1 second (FEV1), over time. Participants will receive either oral belumosudil or placebo tablets alongside azithromycin and standard immunosuppressive therapy. The study includes two main treatment periods: up to 26 weeks for those not entering the open-label extension (OLE) and up to 52 weeks for those who do. The overall study duration is up to 31 weeks without OLE and extends to 57 weeks for those in OLE, with continued visits every 12 weeks for participants in the long-term OLE phase. During the study, participants will attend up to 10 visits without OLE or up to 16 visits with OLE involvement. Researchers will track lung function changes from baseline to Week 26, focusing on FEV1. Safety and efficacy will be monitored throughout the study, with extended follow-up visits for those in the long-term extension. This careful monitoring helps evaluate the treatment's impact on lung transplant rejection and overall lung health.

Researchers are evaluating the safety and performance of Abbott's Structural Heart (SH) devices used in routine hospital practices and standard-of-care procedures for patients with various heart diseases including septal defects and valvular heart disease. This Registry study collects real-world data to meet regulatory requirements such as the European Union Medical Device Regulations that mandate active post-market clinical follow-up for all commercially available devices. The study is designed to include patients who undergo procedures involving Abbott SH devices and to provide ongoing safety and performance data over time. The study includes devices like the Amplatzer Occlusion Devices, which are used to close multiple septal heart defects, and the Epic Surgical Tissue Heart Valve devices, which serve as replacements for diseased or damaged native or prosthetic aortic or mitral valves. Patients may be enrolled before or shortly after the implant procedure, with specific follow-up timeframes varying by device type. Follow-up visits align with routine care and may be conducted in person, by phone, or virtually. The follow-up period ranges from discharge or 7 days post-procedure to as long as 10 years, depending on the device, to ensure thorough monitoring of device safety and effectiveness. Participants will provide informed consent and be monitored through their standard care visits, with data collected at multiple points including discharge, short-term (1-3 months), mid-term (6 months), and long-term (12 months or up to 10 years) follow-ups. A special sub-study focuses on specific surgical valve sizes at European sites for regulatory approval purposes. The study aims to enroll about 500 subjects per year over at least five years at approximately 25 sites worldwide, with assessments including clinical outcomes and device-related safety measures.

Researchers are evaluating the impact of an Assisted Fluid Management (AFM) system, an artificial intelligence-based decision support tool, on postoperative outcomes in high-risk patients undergoing major abdominal surgery. The study focuses on comparing this AFM-guided goal-directed fluid therapy (GDFT) to usual care, aiming to reduce major postoperative complications within 30 days after surgery. This trial is designed as a multicenter stepped-wedge, cluster-randomized clinical study, addressing the challenges of inconsistent GDFT implementation and variability in fluid management among care providers. Participants will receive either routine fluid care, maintaining mean arterial pressure (MAP) between 65-70 mmHg, or fluid management guided by the AFM system, which recommends fluid bolus administration while maintaining MAP in the same range. The AFM system assists clinicians by suggesting fluid boluses, analyzing their hemodynamic effects, and continuously reassessing patient needs, aiming to improve adherence to GDFT protocols. Centers transition from control (routine care) to intervention (AFM-guided therapy) phases at randomly assigned times. During the study, participants will be monitored for major postoperative complications up to 30 days after surgery to assess the composite outcome of any such events. The trial includes assessments of fluid administration practices and patient hemodynamics, with data collected across multiple centers. Participants must provide informed consent, and safety is monitored throughout the postoperative period, ensuring comprehensive evaluation of the AFM system's impact on surgical outcomes.

Researchers are evaluating the impact and effectiveness of Cardiac Resynchronization Therapy (CRT) on functional capacity in adult congenital heart disease (ACHD) patients with a systemic right ventricle (SRV). This trial aims to provide the first evidence of CRT's benefits or limitations in this specific group of patients who experience heart failure and SRV. The study is designed as a double-blind randomized crossover trial with a total follow-up of six months involving 40 patients. Participants will be randomly assigned to two groups: one group will have their CRT device activated (CRT ON) for three months followed by deactivation (CRT OFF) for three months, while the other group will receive the interventions in the reverse order. The CRT ON mode involves biventricular pacing, and CRT OFF involves inactive or univentricular pacing. This crossover design allows each participant to experience both treatment modes during the study period. During the trial, participants will undergo assessments including a 6-minute walk test to measure changes in functional capacity between the two treatment periods. Researchers will monitor patient outcomes to evaluate CRT's impact on heart function and quality of life. The study includes careful follow-up visits and evaluations to ensure safety and collect data on CRT efficacy over the six-month period.

Congenital heart defects (CHD) are a major cause of birth defects affecting millions worldwide, including about 41,000 newborns each year in Europe. This study focuses on infants with critical CHD who often face neurodevelopmental disorders (NDD), which impact cognitive, emotional, and behavioral development. These disorders can affect language, learning, motor skills, social abilities, and more, significantly influencing quality of life beyond heart issues. Researchers aim to detect developmental delays as early as six months of age and understand factors contributing to these neurodevelopmental challenges. The study involves several assessments and sample collections. Infants will undergo neurodevelopmental evaluation using the Bayley-IV test administered by a neuropsychologist. Biological samples from the mother, father, infant, placenta, and meconium will be collected at various times around delivery and surgery to analyze genetic, metabolic, and other markers. Questionnaires about maternal diet, lifestyle, and stress will also be completed. Additionally, cardiovascular and developmental follow-up data, fetal ultrasounds, echocardiography, and postoperative brain MRIs will be gathered. Participants will be monitored up to six months of age to evaluate developmental outcomes, particularly the prevalence of delays. Researchers will collect detailed clinical and biological data to explore potential causes and risks for NDDs in infants with CHD. The study requires consent from both parents and includes support for families while tracking developmental progress and health through scheduled assessments and sample analyses.

Researchers are collecting real-world data on the use of commercially available Boston Scientific drug-eluting devices for treating lesions in the peripheral blood vessels. This study aims to include patient populations not previously well represented in peripheral vascular disease trials and to gather health economic information to support the safe use of these devices. Participants will be treated with any eligible Boston Scientific drug-eluting device, such as the Ranger Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter or the ELUVIA Drug-Eluting Vascular Stent System. These devices are used to treat lesions located in the peripheral vasculature. The study is global, prospective, open-label, non-randomized, and involves multiple centers. During the study, researchers will monitor major adverse events and lesion patency over 12 months. Participants will be followed to assess the safety and effectiveness of the devices in real-world settings. Health economic data will also be collected to better understand the broader impact of these treatments.

Researchers are investigating the effects of different fluid removal rates during renal replacement therapy (RRT) in intensive care unit (ICU) patients with acute kidney injury (AKI) who experience fluid overload. Fluid overload in these patients is linked to increased complications and death, and reducing it through ultrafiltration (UFnet) may improve outcomes. The study compares a moderate rate of fluid removal to a lower rate to see if targeting both fluid balance and tissue perfusion improves kidney, heart, and lung health. The study involves two main treatment approaches during RRT. One group will receive a higher UFnet rate of 2 ml/kg/h, adjusted for tolerance and tissue perfusion, aiming to reduce excess fluid to the patient's normal body weight. If needed, the rate may increase to 3 ml/kg/h. The other group will have a lower UFnet rate between 0 and 1 ml/kg/h, adjusted as necessary to stabilize fluid balance. If intolerance or tissue hypoperfusion occurs, ultrafiltration will be paused temporarily. Participants will be closely monitored throughout the study. Researchers will assess organ function, fluid balance, tissue perfusion, and safety measures including hemodynamic tolerance. The primary outcome is the number of days without needing organ replacement therapy over 30 days. This approach aims to determine whether a moderate fluid removal strategy guided by tissue perfusion can improve overall and kidney-specific recovery in critically ill patients with fluid overload undergoing RRT.

Researchers are studying the link between cannabis use and lung cancer, focusing on patients aged 18 to 59 years treated for primary lung cancer. Cannabis is the most widely used drug globally, and although previous research often suggests minimal lung risks, concerns arise from clinical observations of advanced lung cancers in young heavy cannabis users. This study aims to explore the possible role of cannabis in lung cancer development and characteristics, noting differences in tumor types and severity among cannabis users compared to tobacco smokers and non-smokers. The study involves collecting blood and hair samples from participants to analyze potential biological markers related to cannabis use and lung cancer. Participants include patients from specified hospitals who have lung cancer at any stage. The research will monitor cannabis use status and its association with cancer profiles, but no drug treatments or other interventions are administered within the study. Participants will undergo sample collection and provide information about their cannabis use. Researchers will assess the percentage of patients who are active cannabis smokers, defined as those smoking at least 10 joints per year for at least one year. The study includes ongoing monitoring of clinical data and tumor characteristics to better understand cannabis's impact on lung cancer. Participation lasts as long as necessary to collect relevant data from consenting patients within the age range.

Researchers are evaluating the safety and performance of Cook's custom-made stent-graft devices used for endovascular treatment of complex diseases of the aorta, including abdominal, thoracoabdominal, and aortic arch aneurysms, as well as chronic aortic dissections. This study collects real-world data on how these devices are used to support ongoing market availability and help with post-market product surveillance and technology development. The study involves the use of Cook's custom-made endovascular grafts as a procedure to treat these complex aortic conditions. Participants receive treatment tailored to their specific aortic disease using these devices, aiming to address aneurysms and dissections effectively. Participants will be monitored for treatment success over 12 months and safety outcomes within 30 days after the procedure. The study includes clinical follow-up visits and data collection from medical records. Researchers will assess the performance and safety of the devices through this ongoing observation and follow-up during the study period.