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Thromboembolism clinical trials

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NCT ID: NCT06218095 Active, not recruiting - Clinical trials for Venous Thromboembolism

Pregnancy and Postpartum Period Venous Thromboembolism and Simulation

Start date: May 15, 2023
Phase: N/A
Study type: Interventional

This research will be carried out to determine the effectiveness of teaching thromboembolism risk assessment during pregnancy and postpartum period to midwifery students using a high-tech simulation method. Thromboembolism during pregnancy and postpartum period is one of the preventable causes of maternal deaths. For this reason, it is important to determine the thromboembolism risk of pregnant women and postpartum women by midwives before complications develop and to plan preventive interventions. The aim of the research is to provide midwifery students with the ability to evaluate the risk of thromboembolism before clinical experience through high-tech simulation application. Goals; - To increase midwifery students' skills in assessing thromboembolism risk during pregnancy and postpartum period before clinical practice. - To increase the self-confidence and satisfaction of midwifery students with simulation application in pregnancy and postpartum thromboembolism risk assessment skills. - To develop midwifery students' quick, critical thinking and decision-making skills in assessing the risk of thromboembolism before clinical practice. - To help midwifery students visualize the risk of pregnancy and postpartum thromboembolism, which has an important place in terms of maternal deaths, by creating a clinical environment with a case scenario. - To determine the effectiveness of midwifery teaching through case scenario simulation application with the risk of pregnancy and postpartum thromboembolism, and to increase students' learning and clinical practice skills.

NCT ID: NCT06206967 Not yet recruiting - Clinical trials for Pulmonary Thromboembolism

Promotion of Active Lifestyle in Thromboembolism Patients

ACTIVATEP
Start date: January 20, 2024
Phase: N/A
Study type: Interventional

Patients who have suffered a pulmonary thromboembolism used to reduce their activity levels because of the symptoms and the fear to suffer other pulmonary thromboembolism. These patients often have sequelae after the hospitalization that previous studies have associated with a lack of physical activity. The main objective of this research is to investigate the efficacy of a rehabilitation program for promotion higher activity levels in quality of life and self-perceived discapacity of thromboembolism patients.

NCT ID: NCT06201598 Recruiting - Cerebral Aneurysm Clinical Trials

Prospective, Single-Arm, Multicenter Study to Evaluate the Effectiveness and Safety of Endovascular Treatment in Patients With Cerebral Aneurysms Using P64 and P48 Flow-Diverter Stents

pSPAIN_HPC
Start date: January 12, 2024
Phase:
Study type: Observational

The use of flow-diverting stents for the endovascular treatment of cerebral aneurysms has proven to be effective and efficient in several clinical studies, leading to its widespread adoption. Devices with a higher number of filaments have a greater flow-diverting effect and less variation when there are changes in the caliber of the underlying vessel or in curved vessels. However, ischemic complications secondary to their implantation have been reported, prompting the development of various strategies to reduce their thrombogenicity. Phenox is the only company to date that has developed an anti-thrombogenic coating, known as HPC (Hydrophilic Polymer Coating), which, when applied to the p64 MW HPC and p48 MW HPC devices, has shown to reduce the likelihood of thromboembolic complications associated with their implantation.

NCT ID: NCT06196918 Recruiting - Glioma, Malignant Clinical Trials

Efficacy and Safety of Rivaroxaban in the Prevention of Venous Thromboembolism in Glioma Patients

Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Glioma is a common brain tumor with a high risk of venous thromboembolism during treatment, especially in the months after surgery. Postoperative lower extremity dyskinesia in patients with gliomas is considered as a high-risk factor for venous thromboembolism. Rivaroxaban, as an oral anticoagulants, has similar effect in the prevention and treatment of tumor-related venous thromboembolism compared to low molecular weight heparin. Given the lack of prospective supporting data, the efficacy and safety of rivaroxaban in the prevention of postoperative venous thromboembolism in glioma patients with postoperative lower extremity dyskinesia need to be established.

NCT ID: NCT06195540 Not yet recruiting - Pulmonary Embolism Clinical Trials

RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

RIVACAST
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.

NCT ID: NCT06194617 Recruiting - Pulmonary Embolism Clinical Trials

Rivaroxaban in Elderly Chinese Venous Thromboembolism Patients

Start date: April 1, 2021
Phase:
Study type: Observational

There's no unified recommendation in clinical practice regarding adjusting dosages for different patient types, especially when adverse events occur. While rivaroxaban typically doesn't require coagulation monitoring, in elderly patients, particularly those with multiple medications, finding appropriate lab indicators becomes crucial to gauge its anticoagulant effect. This aids in evaluating precise rivaroxaban dosing for the elderly, balancing bleeding risks and recurrence. Clinical pharmacological studies suggest that drug pharmacokinetics and pharmacodynamics in different populations can guide dosage optimization. Hence, this study aims to provide a basis for optimizing dosing regimens in high-risk elderly patients in China by exploring pharmacokinetic and pharmacodynamic indicators in clinical practice.

NCT ID: NCT06193863 Not yet recruiting - Clinical trials for Congenital Heart Disease

An Observational Study to Learn More About How Safe Rivaroxaban is And How Well it Works in Children With Congenital Heart Disease Who Had a Heart Surgery Called the Fontan Procedure

Start date: May 31, 2024
Phase:
Study type: Observational

This is an observational study in which the data from children with congenital heart disease will be collected and studied. These children will include those who are prescribed rivaroxaban by their doctors after a heart surgery called the Fontan procedure. Congenital heart disease (CHD) is a heart problem that some children are born with. It sometimes requires a surgery called the Fontan procedure to improve the blood flow in the body. The Fontan procedure can increase the risk of the formation of blood clots in the blood vessels (called thrombosis), which might lead to death. The study drug, rivaroxaban, is an approved treatment for preventing the formation of blood clots. It is a type of anticoagulant that prevents the blood from clotting by blocking a protein responsible for it. Rivaroxaban can increase the risk of bleeding. A previous study suggested that the number of major bleeding episodes did not differ much while taking rivaroxaban compared to aspirin in children with CHD who had undergone the Fontan procedure. However, there is limited information available for Japanese patients. To better understand the safety and potential risks of this drug in children, more knowledge is needed about the use of rivaroxaban in the real world. The main purpose of this study is to learn more about the occurrence of major bleeding or non-major bleeding in children who were treated with rivaroxaban. Major bleeding is defined as a serious or life-threatening bleeding episode that can have an impact on a person's health and requires medical attention. Non-major bleeding is defined as a type of bleeding that may negatively impact a person's health if not treated. The data will be collected from December 2023 to June 2026. Researchers will observe each participant for up to 30 days after stopping the treatment or for a maximum of 2 years. In this study, only available data from regular health visits will be collected. No visits or tests are required as part of this study. Researchers will use the medical records or interview the children and/or their guardians during regular visits.

NCT ID: NCT06190392 Not yet recruiting - Pulmonary Embolism Clinical Trials

Effect of a Global Simplified Strategy on Thromboembolic Events in Emergency Department Patients With Suspected Pulmonary Embolism

MODS STRATEGY
Start date: January 2024
Phase: N/A
Study type: Interventional

Pulmonary embolism (PE) is frequently suspected in emergency departments (ED) patients which often leads to the prescription of DDimer testing and irradiative chest imaging (Computed Tomographic Pulmonary Angiogram CTPA in most cases).[1] Indeed, an increased use of CTPA has been reported without clear benefit in terms of prognosis.This increased use is reportedly associated with potential overdiagnosis of PE, increased cost, length of ED stay, and side effects from both chest imaging and undue anticoagulant treatments. The standard diagnostic strategy for PE work up includes three steps with an initial evaluation of clinical probability, followed by D-dimer testing if indicated, followed by chest imaging if necessary - Computed tomographic pulmonary angiogram CTPA being the imaging modality of choice. A large European prospective study has reported that the use of CTPA has constantly increased without change in the diagnostic yield. In order to reduce the use of CTPA, it has been validated that in patients with a low likelihood of PE, the D-dimer threshold for ordering CTPA can be raised at 1000 ng/ml. It has been validated that a low likelihood of PE can be determined either with the YEARS or the PEGeD clinical decision rules. These latter two include one common item being "Is PE the most likely diagnosis". A retrospective cohort study of 3330 patients reported that using this sole question of "Is PE the most likely diagnosis" can be safely used to raise the D-dimer threshold to 1000 ng/ml, and that this performs as well as YEARS and PEGeD. This simple question is easier to use by emergency physicians compared to complex ones, which are reportedly seldom used by emergency physicians. Therefore, the validation of the "PE unlikely" simple and straightforward decision rule could increase physicians' adherence and therefore limit the use of chest imaging. The hypothesis of this prospective study is that the likelihood of PE assessed to elevate the DDimer threshold to 1000 ng/ml can be estimated by the sole question of "is PE the most likely diagnosis", and to validate a global simplified diagnostic strategy for PE in the ED. The intervention will be the patient's management with a simplified global strategy. Whether PE is the most likely diagnostic will be assessed by the unstructured implicit clinician's estimation. In patient with a clinical suspicion of pulmonary embolism: DDimer testing will be performed. If the likelihood of PE is low (PE is not the most likely diagnosis), then threshold for DDimer testing will be 1000 ng/ml. If the likelihood of PE is high (PE is the most likely diagnosis), then the age-adjusted DDimer threshold will be applied.

NCT ID: NCT06189313 Not yet recruiting - Clinical trials for Cardiovascular Diseases

CLEANer Aspiration for Pulmonary Embolism

CLEAN-PE
Start date: July 22, 2024
Phase: N/A
Study type: Interventional

To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).

NCT ID: NCT06180889 Recruiting - Clinical trials for Knee Arthroplasty, Total

Factor XI inhibiTion for the Prevention of Venous Thromboembolism in Patients Undergoing Total Knee Arthroplasty

Start date: December 20, 2023
Phase: Phase 2
Study type: Interventional

This study was to compare the study drug KN060 to enoxaparin, for the prevention of blood clotting and safety in patients undergoing total knee arthroplasty (TKA).