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NCT07666256
Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in total interruption of portal venous inflow and representing the most severe form of portal vein thrombosis. A small proportion of patients may remain asymptomatic for prolonged periods because of sufficient collateral compensation; however, most develop complications of portal hypertension when collateral flow is inadequate, including gastroesophageal variceal bleeding and ascites. Among these, gastroesophageal variceal bleeding is the most life-threatening, and its management is more challenging-with a higher risk of rebleeding-than in patients without portal vein thrombosis. Occlusive portal vein thrombosis (OPVT) is defined as complete thrombosis of the main portal vein trunk, resulting in total interruption of portal venous inflow and representing the most severe form of portal vein thrombosis. A small proportion of patients may remain asymptomatic for prolonged periods because of sufficient collateral compensation; however, most develop complications of portal hypertension when collateral flow is inadequate, including gastroesophageal variceal bleeding and ascites. Among these, gastroesophageal variceal bleeding is the most life-threatening, and its management is more challenging-with a higher risk of rebleeding-than in patients without portal vein thrombosis. Transjugular intrahepatic portosystemic shunt (TIPS) is an effective minimally invasive therapy for portal hypertension-related complications; however, in OPVT, technical feasibility largely depends on successful portal vein recanalization. To improve TIPS success in OPVT, our group-together with domestic and international investigators-has explored several adjunctive access routes and technical modifications, including percutaneous transhepatic or transsplenic portal vein recanalization TIPS (PVR-TIPS); transjugular portal cavernous collateral-caval shunt (TCCS); transjugular mesenteric-caval shunt (TMCS); transjugular spleno-caval shunt (TSCS); and surgically assisted hybrid procedures. Although these strategies have improved technical success rates to some extent, their applicability remains limited. In patients with extensive thrombosis involving intrahepatic portal vein branches, in those without a feasible splenic venous puncture route, or in patients with prior splenectomy, percutaneous transhepatic and transsplenic approaches are often not possible. Moreover, in patients with poor hepatic reserve and/or ascites, laparotomy-assisted hybrid procedures substantially increase invasiveness and perioperative risk. In this context, the present project aims to systematically investigate and evaluate ultrasound-guided percutaneous mesenteric vein (MV) puncture as an adjunctive access strategy for interventional treatment of OPVT. This technique uses ultrasound-guided percutaneous puncture of the MV to establish antegrade portal venous access, thereby facilitating subsequent portal vein recanalization and/or shunt creation.
NCT06357403
The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are: * What is the association between antiXa and VTE? * What is the association between antiXa and symptomatic, respectively incidental, VTE? * How is pharmacological anticoagulation with enoxaparin related to measured antiXa? * What is the association between antiXa and bleeding complications. * What is the incidence of venous thromboembolism in patients treated at an intensive care unit? * How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.
NCT07213778
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
NCT07599384
Investigators are building an empirical evidence base for real-world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.
NCT04924322
The goal of the CRETE Studies is to investigate the newly identified age-dependent heterogeneity in the efficacy of enoxaparin in reducing the risk of central venous catheter-associated deep venous thrombosis in critically ill children.
NCT06838364
Introduction Peripheral venous catheterization (PVC) is the most common invasive procedure in healthcare worldwide. Improving the success rate of PVC on the first attempt is crucial for patients, as it impacts pain, anxiety, the risk of extravasation, rapid access to care, and the patient-provider relationship. For healthcare providers, a higher success rate enhances self-confidence and autonomy, while institutions benefit from improved reputation and reduced costs. In the Poitiers hosptial, one in ten catheters is used in imaging services, with CT scan departments accounting for 66.3% of catheter usage due to iodinated contrast injections. Literature suggests two techniques to enhance PVC success: ultrasound-guided and infrared illumination methods. These techniques appear effective primarily for patients with difficult venous access. Additionally, the A-DIVA clinical score has been developed to predict first-attempt success rates. However, no studies in Europe have compared the effectiveness of these two techniques in imaging settings or based on the A-DIVA score. This study aims to identify the most effective technique for PVC in patients with difficult venous access. Objectives Compare the proportion of successful PVCs on the first attempt among the classical method (Gold Standard), ultrasound-guided technique, and infrared illumination technique in adult patients with difficult venous access. Compare the proportion of successful PVCs on the second attempt (if the first attempt fails) among the three techniques. Compare the total number of attempts required for successful PVC. Evaluate the maximum pain experienced by patients during successful PVC. Assess overall patient satisfaction following successful PVC. Evaluate operator satisfaction with the procedure. Measure the time taken for catheterization from material preparation to successful catheter placement. Analyze the fallback strategies chosen by operators after a failed attempt (e.g., calling a colleague, continuing with the classical method, using ultrasound guidance, infrared illumination, or abandoning the procedure). Describe the catheter sizes chosen by operators based on the A-DIVA score and the number of failed attempts. Methodology This is a prospective, controlled, randomized, three-arm, single-center, superiority trial involving patients with difficult venous access. Inclusion criteria include: Patients aged 18 years or older. Patients scheduled for a CT scan requiring PVC. Patients with an A-DIVA score of 2 or higher. Patients capable and willing to comply with study procedures. Patients covered by social security or through a third party. Patients providing written informed consent after receiving clear information about the study. Exclusion criteria include: Patients with contraindications for PVC (e.g., presence of an arteriovenous fistula, orthopedic or vascular prosthesis, history of mastectomy, etc.). Patients with contraindications for iodinated contrast injection as defined by the French Society of Radiology. Patients already included in the study. Vulnerable populations (e.g., minors, pregnant or breastfeeding women, individuals deprived of liberty). Intervention Groups Control: Classical method based on clinical examination (visualization and palpation). Experimental: Ultrasound-guided method. Experimental: Infrared illumination method. Sample Size and Duration A total of 249 patients will be enrolled, with 82 patients in each group. The inclusion period will last 12 months, and each participant will be involved for a maximum of 4 hours. The total duration of the clinical investigation will be 1 year and 4 hours. Outcome Measures The primary outcome is the proportion of successful PVCs on the first attempt, defined as the administration of 5 ml of NaCl without reported pain or visible edema. The total number of skin penetrations by the catheter will be recorded. Maximum pain will be assessed using a numerical rating scale (0-10). Patient satisfaction will be measured using a similar numerical scale. Operator satisfaction will also be evaluated on a scale from 0 (very dissatisfied) to 10 (very satisfied). Time for catheterization will be recorded in minutes, starting from the preparation of the PVC tray until successful catheter placement. The fallback strategy after a failed attempt will be documented. The size of the catheter chosen for each attempt will be recorded. Statistical Analysis The primary outcome will be compared among the three groups using ANOVA, followed by pairwise comparisons using Tukey's test if significant differences are found. Expected Outcomes Identifying the most effective PVC technique could increase the likelihood of first-attempt success in adults with difficult venous access. Benefits for Patients Reduced pain and discomfort from multiple attempts. Decreased risk of infection and extravasation. Maintenance of venous integrity. Sustained trust in the patient-provider relationship.
NCT06958731
Background: Ultrasound guidance is an important technique to improve the success rate of internal jugular vein catheterization (IJVC) at the first-attempt, however, both long-axis in-plane and short-axis out-of-plane techniques have their own disadvantages. The T-shaped ultrasonic probe invented by us combined with the help of laser positioning and 3D printing manipulator could realize real-time bi-plane guidance of the needle short-axis out-of-plane and long-axis in-plane. With the help of the Single-operator Laser-assisted T-shaped probe, the whole process of needle insertion, guide wire placement and catheter placement can be visualized, which is expected to improve the success rate on the first-attempt. Objective: The primary outcome was the first-attempt success rate of initial RIJV catheterization without complications. The completion of the catheterization was defined as the presentation of the CVP waveform on the monitor. The secondary outcomes included first-attempt puncture success rate,first-attempt catheterisation success rate,overall catheterisation success rate,first-attempt needle tip location,first-attempt needle tip midline placement rate,number of needle direction adjustments,number of ultrasound probe repositionings, number of puncture attempts,first-attempt localisation time,first-attempt guidewire insertion success time,overall catheterisation success time. Design, Setting, and Participants: This single-center, prospective, parallel-group, randomized controlled study enrolled surgical patients over 18 years and older (ASA grade Ⅰ-Ⅳ) who required IJVC ,fully understands the benefits and risks of the study, participates voluntarily, and signs the informed consent form in the First Hospital of Jilin University. The exclusion criteria were congenital abnormal development of the internal jugular vein; prior puncture at the same site last month; puncture site injury, infection, or hematoma; right neck surgery history and neck fixation due to surgery or injury. The participants were randomized into the traditional ultrasound-guidance group or the single-operator Laser-assisted T-shaped probe ultrasound-guidance group. After inducing general anesthesia, ultrasound-guided internal jugular vein catheterization was performed by the experienced operators. Interventions: 352 patients were stratified into eight subgroups based on whether common carotid artery coverage exceeded 50% ,internal jugular vein depth exceeded 10mm , and internal jugular vein anteroposterior diameter exceeded 10mm . Each subgroup generated an independent randomisation sequence according to the block randomisation principle (T-mode ultrasound-guided group and 'long-axis plane' ultrasound-guided group). Upon enrolment, new subjects were assigned to corresponding subgroups based on stratification factors. Within each subgroup's dedicated random sequence, the allocation plan (T-shaped ultrasound guidance group or 'long-axis plane' ultrasound guidance group) was sequentially retrieved and marked. The next subject in that subgroup would receive the subsequent plan in the sequence. The operating team comprised six physicians (including two residents, two specialists, and two anaesthesiologists), who were not involved in other aspects of the study. Given the significant technical differences between the two approaches, the operators, equipment assistants, and research assistants were aware of the groupings. Conversely, participants' families were unaware of the groupings and could withdraw from the trial at any time. All data were collected and analysed by the same research assistant.
NCT06472518
* Iliofemoral DVTs (IF DVTs) are vascular disorders associated with high morbidity and mortality, which can be complicated by long-term post-thrombotic syndrome (PTS). * Pharmaco mechanical thrombolysis (PMT) is an innovative endovascular technique involving in situ fibrinolysis of the thrombus in the acute phase of thrombosis, followed by mechanical extraction by fragmenting the thrombus. * The American ATTRACT study showed that management by catheter-directed thrombolysis and/or PMT in the acute phase is safe and effective at 2 years in a subgroup of DVTif compared with anticoagulation (18% moderate or severe SPT with thrombolysis vs. 28% without thrombolysis). * PMT-DVT will be the first study to assess the medium (30 months) and long-term (60 months) efficacy of PMT in the French context, using data from the French National Health Data System.
NCT07586748
Pressure sores, also known as pressure ulcers, are a significant complication among hospitalized patients, particularly those who are immobile or require prolonged care. Intermittent pneumatic compression (IPC) devices are routinely used to prevent deep vein thrombosis (DVT); however, they have been associated with pressure injuries, especially over bony prominences such as the ankles. Furthermore, IPC devices may lead to less commonly recognized complications, including compartment syndrome and bullous lesions. This study aims to assess the incidence and characteristics of pressure sores related to IPC device use, focusing on ankle lesions.
NCT07538609
This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.
NCT05491980
The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.
NCT07183592
In the intensive care unit, patients' care and secure drugs administration require a central venous catheter. These invasive devices can lead to complications, particularly infections. Most preventive recommendations focus on catheter insertion, line handling, and dressings. Few recommendations adress catheter dwell time, which is certainly the main source of infection. Part of the prevention strategy is the regular and systematic replacement of infusion sets , as they may become contaminated during use, mainly through the hands of healthcare professionals. Prolonged use increases the risk of infection. Infusion lines changes involve disconnecting the old sets, discarding infusion devices containing drug residues, and replacing them with new sterile devices. Current international guidelines recommend replacing these sets every 4 days, and the Center for Disease Control and Prevention recommends not exceeding 7 days. Replacing these devices requires the time of qualified nurses, numerous sterile medical devices, and medications. In addition to the intended effect on infection prevention, the procedure has impacts on workload and costs. The objective of the study is to demonstrate that changing infusion set every 7 days does not increase the rate of central venous catheters related infections compared with changing infusion set every 4 days.
NCT07529756
The goal of this observational study is to gather additional safety and performance (effectiveness) data on the device for the treatment of symptomatic lower extremity venous obstructions and occlusions. The main questions the study aims to answer are: * What is the observed rate of safety events through the 30-day follow-up? * What is the rate of technical success (acute procedural success) achieved at the index procedure? Participants already undergoing treatment with the Recana as part of their regular medical care will be followed for 1 year.
NCT07582107
This study looks at how to place port catheters safely and accurately in children who need long-term intravenous treatment. For these treatments to work well and to avoid problems such as heart rhythm issues, blood clots, or infections, the tip of the catheter must be in the correct position inside a large vein near the heart. Doctors commonly use two different methods to estimate the correct catheter length. One method uses body measurements and surface landmarks on the chest. The other method, called intracavitary electrocardiography (IC-ECG), uses changes in the heart's electrical signal during the procedure to guide placement. In this study, researchers compared these two methods in children. They measured how closely the results of the two techniques matched and how much they differed. After the catheter was placed, chest X-rays were used to check whether the catheter tip was in the correct position. The goal of this study is to determine whether the simpler anatomical method can provide accurate and clinically reliable results compared to the IC-ECG method.
NCT07567456
This study investigates the effectiveness of pulsatile flushing techniques in reducing blockage in Tunnelled Central Venous Access Device (T-CVAD) among patients undergoing haemodialysis (HD) treatment at multiple renal centres within the Hospital Authority (HA) in Hong Kong. With limitation in single service protocol for each cluster of renal units, it is designed as a prospective, parallel, cluster non-randomised controlled trial involving 591 patients from 14 renal units. In order to identify the most effective flushing technique for T-CVAD maintenance, survival analysis on clinical effectiveness, in terms time-to-event blockage of the T-CVAD, among three trial arms: 1) Intervention Group A (IG-A) using pulsatile flushing technique with 0.4 second pause time interval; 2) Intervention Group B (IG-B) using pulsatile flushing technique with 1 second pause time interval; 3) Control Group (Con) using standard bolus flushing technique. The findings facilitate development of best practice for T-CVAD maintenance, optimise T-CVAD maintenance protocols, and ultimately improve patient outcomes. This groundbreaking study is expected to signify substantial progression in the nursing management of HD and T-CVAD.
NCT06394739
The purpose of this research is to collect information about how the RevCore Thrombectomy Catheter works to treat stent blockages.
NCT07560202
Portal vein thrombosis (PVT) is a common complication in patients with liver cirrhosis and is associated with increased morbidity due to worsening portal hypertension and hepatic decompensation. The clinical presentation and radiological patterns of PVT vary widely, and the factors predicting its development remain incompletely understood. This observational study will include adult patients (≥18 years) with established liver cirrhosis who are admitted to the Department of Gastroenterology and Tropical Medicine, Al-Rajhi Liver Hospital, Assiut University. Eligible participants will undergo routine screening for PVT using Doppler ultrasonography, with confirmation by contrast-enhanced computed tomography when indicated. The study aims to evaluate the clinical characteristics, laboratory parameters, and radiological features of PVT. Cases of PVT will be classified according to extent (partial or complete) and anatomical location (main portal vein, right branch, left branch, or combined involvement). Clinical and laboratory data will be analyzed to identify potential predictors associated with the development and severity of PVT. The findings of this study are expected to improve understanding of the risk factors and radiological patterns of PVT in cirrhotic patients, contributing to better risk stratification and clinical management.
NCT06417541
Central venous (CVC) is essential in modern healthcare but unfortunately associated with complications, including thrombosis. In a recently published study, it was showed that 12 out of 12 deceased patients had subclinical CVK-related thrombosis (Rockholt et al.). To shed light on this problem, the current studies were designed. In sub-study 1, deceased patients with CVC who are referred for clinical autopsy are included. Before the autopsy, the deceased will be examined with a photon-counting computed tomography (CT) scan and the results will be compared. In sub-study 2, living patients with CVC who are referred for various CT scans without contrast, are included. After informed consent, the patient will be examined with the photon-counting CT, whose reliability has been validated in Part 1 and the incidence of subclinical CVC-related thrombosis will be reported.
NCT03216005
To evaluate the safety and effectiveness of the BlueLeaf System for the restoration of venous competence for the treatment of symptomatic chronic venous insufficiency (CVI).
NCT07228585
This study aims to compare the effects of kinesiology taping and interval exercise on reducing symptoms, improving quality of life, and vital parameters in individuals with venous insufficiency. The study will be conducted at the Department of Cardiovascular Surgery, Faculty of Medicine, Necmettin Erbakan University, Konya, and will involve individuals aged 18 to 65 who have been diagnosed with venous insufficiency. Participants will be selected according to inclusion criteria and randomised into three groups. These groups will consist of a group receiving kinesiology taping and lifestyle recommendations, a group receiving kinesiology taping combined with interval exercise and lifestyle recommendations, and a control group receiving only lifestyle recommendations. Participants will be followed up for eight weeks, with assessments conducted twice: before and after treatment. In kinesiology taping groups, taping will be applied twice a week for eight weeks, with a total of sixteen sessions. During application, the lymphatic correction technique will be used to increase venous circulation. Taping will begin over the popliteal vein and be applied along the gastrocnemius, soleus, and tibialis posterior muscles with a tension of fifteen to twenty per cent. Participants will inform the physiotherapist if they experience any discomfort or skin sensitivity related to the bandaging, and skin reactions and tolerance levels will be monitored during weekly check-ups. In the group undergoing interval exercise, participants will participate in a mild to moderate exercise programme for thirty to forty minutes, three days a week for eight weeks. The exercises will be performed under the supervision of a physiotherapist and will be of an intensity equivalent to levels three to five on the Borg scale. The programme will include a five-minute warm-up phase, a twenty-minute main exercise section, and a five-minute cool-down period. The main section will consist of three phases, with low-intensity, moderate-intensity, and recovery exercises applied alternately. In the low-intensity section, light-paced walking and step movements will be performed; in the moderate-intensity section, fast-paced walking, ankle pumping movements, squats or calf raises will be performed; in the recovery section, light walking or wrist movements will be preferred. The main exercise will be completed after the cycle is repeated four times, followed by light stretching movements and diaphragmatic breathing exercises during the cool-down phase. Exercise compliance will be monitored on a weekly basis. Standard lifestyle recommendations will be provided to all groups participating in the study. As lifestyle changes in venous insufficiency have both therapeutic and symptom-reducing effects, participants will be given detailed information on this subject. Lifestyle recommendations include increasing physical activity habits such as walking briskly for at least thirty minutes daily and using stairs. As part of leg elevation recommendations, it will be advised to keep the legs above heart level for fifteen to twenty minutes, two or three times a day. Individuals whose jobs require them to stand still for long periods will be advised to take a short walk every thirty minutes. Nutritional recommendations will emphasise reducing salt intake, drinking at least two litres of water daily, and eating fibre-rich foods. Smoking participants will be counselled to quit and asked to avoid wearing tight trousers and high-heeled shoes. As part of skin care, participants will be instructed to use moisturiser once a day to prevent dryness and cracking in the lower extremities. Lifestyle recommendations will be presented to participants via a brochure, and participants in the control group will also follow the same recommendations. The conditions of the study and safety measures have been determined with great care. All procedures will be performed by experienced physiotherapists, taking into account the participants' medical history and contraindications. Assessments will be conducted twice: at the beginning and at the end of the eight-week period. Measurements will include ankle circumference, pain intensity at rest, during sleep and during exercise, blood pressure, heart rate, respiratory rate, body temperature, oxygen saturation, Borg scale assessment, physical activity level measurement, functional capacity assessment, central sensitisation level and quality of life in venous insufficiency. The six-minute walk test will be used to assess functional capacity, the visual analogue scale will be applied for pain, this parameter will be examined using the central sensitisation inventory, and quality of life will be assessed using scales specific to venous insufficiency. The International Physical Activity Questionnaire will be used for physical activity level.