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Embolism clinical trials

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NCT ID: NCT06232551 Not yet recruiting - Clinical trials for Deep Vein Thrombosis

Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism

eVTE
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

A new algorithm derived from only patient age and components of the complete blood count and basic metabolic panel can identify patients discharged from the hospital who may benefit from a blood thinner (called rivaroxaban) to decrease their risk of blood clots, and for whom the risk of bleeding is minimal. The purpose of this study is to evaluate the use of a pop-up alert, which will be seen by clinicians when a discharging patient has been identified as being someone for whom the risk of blood clots is high, but for whom bleeding risk is estimated to be low. The pop-up alert will be enabled in a sequential fashion for each group of hospitals in 1 month blocks. We will look to see if the pop-up alert changes the number of patients who receive rivaroxaban. We will also measure the outcomes of blood clots and bleeding among all discharging patients.

NCT ID: NCT06212882 Recruiting - Pulmonary Embolism Clinical Trials

Optimization of DE-CTPA Images and Diagnostic Pathway: Using Low Concentration Iodine Contrast Material

Start date: September 1, 2023
Phase:
Study type: Observational

The investigators aimed to compare the image quality and diagnostic performance of DECTPA using lower concentration iodine contrast materials and using normal concentration iodine contrast materials in the evaluation of suspected pulmonary embolism.

NCT ID: NCT06209892 Not yet recruiting - Anticoagulation Clinical Trials

Prolonged Anticoagulation Therapy on the Prognosis of Patients With Left Ventricular Thrombosis

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

A single-center, open-label, exploratory randomized controlled study is proposed with the following objectives: whether prolonging the duration of anticoagulation to 12 months, compared with 6 months of routine anticoagulation, helps to reduce major adverse cardiovascular and cerebrovascular events in patients with left ventricular thrombosis and to reduce recurrence of thrombosis, as well as to assess their bleeding risk. Patients with a definite diagnosis of left ventricular thrombus and age ≥18 years were included in cardiac ultrasound (including general ultrasound and sonography) and other examinations during hospitalization and outpatient visits. Exclusion criteria were detailed in the study protocol. GROUPING: According to the duration of anticoagulation, they were divided into extended anticoagulation group (12 months) and conventional anticoagulation group (6 months). INTERVENTION: This study is planned to extend the administration of rivaroxaban (Pulsatilla) 20 mg to 12 months in the experimental group. The conventional anticoagulation group will take the drug for 6 months Study Endpoints: The primary efficacy endpoint is a major cardiovascular-vascular adverse event at 1 year; the primary safety endpoint is bleeding of grade 3 or higher as defined by the BARC classification at 1 year. Patient Follow-up Program: Subjects will require a total of 12 on-site follow-up visits (one per month) for safety evaluation, efficacy evaluation, medication adherence evaluation, and imaging follow-up at months 3, 6, and 12.

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: NCT06192199 Recruiting - Clinical trials for Acute Pulmonary Embolism

The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonary Embolism

Start date: January 1, 2024
Phase:
Study type: Observational

From January 1, 2023 to December 30, 2023, patients who were suspected of pulmonary embolism and underwent CTPA examination at Nanyang Hospital of Southern Medical University were divided into pulmonary embolism group and non pulmonary embolism group. 1. Collect relevant data, including gender, age, primary disease, CTPA imaging and reports, BNP, troponin, electrocardiogram, cardiac ultrasound, PT, APTT, TT, fibrinogen, D-dimer, etc., and analyze demographic data, pulmonary embolism risk grading, APTT/fibrinogen ratio, and determine their cut-off values through statistical analysis of the two groups. 2. Follow up on the APTT/fibrinogen ratio after anticoagulation treatment and bleeding in the pulmonary embolism group.

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: May 23, 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: NCT06187987 Recruiting - Pulmonary Embolism Clinical Trials

Mechanical Thrombectomy With the FlowTriever Device in Acute Pulmonary Embolism - a Retrospective Analysis

Start date: April 1, 2023
Phase:
Study type: Observational

International guidelines recommend intravenous thrombolysis (IVT) for high-risk pulmonary embolism (PE). In high-risk PE where IVT is contraindicated or has failed, surgical embolectomy or catheter-directed intervention (CDI) is recommended. CDI is also recommended as an alternative in patients with intermediate-risk PE with haemodynamic deterioration during anticoagulation treatment. Although there is a lack of randomized studies comparing CDI to anticoagulation or systemic thrombolysis in PE, several studies and recent meta-analyses have shown that CDI is an effective treatment that is associated with fewer complications than IVT, especially bleeding.

NCT ID: NCT06183944 Recruiting - Pulmonary Embolism Clinical Trials

Data Acquisition Study With Artificial Intelligence and Phenotyping of Patients With Acute Pulmonary Embolism

PEPITE
Start date: December 11, 2023
Phase:
Study type: Observational

The initial aim is to build and validate artificial intelligence tools (machine learning and Natural Language Processing) to acquire and structure data from medical reports at the Centre Hospitalier Intercommunal de Toulon - la Seyne sur mer (CHITS). This project will build upon work previously done by the Department of Epidemiology, Biostatistics and Health Data (DEBDS) at the Centre Antoine Lacassagne (CAL) in Nice, focusing on breast and thyroid cancers. The idea is to validate the transferability of these tools to another establishment with different pathologies and practitioners, specifically the vascular medicine department at CHITS. Subsequently, the aim will be to identify clinically relevant phenotypes in patients with acute pulmonary embolism. Hierarchical clustering methods combined with unsupervised learning (machine learning) will be used to obtain groups of patients who are homogeneous at diagnosis. Evaluating their prognosis at 6 months (recurrence or chronic thromboembolic pulmonary hypertension), account the first 3 months of anticoagulant treatment, would provide an aid to medical decision-making. This research will include a retrospective and a prospective parts. The retrospective part will include patients who have been admitted to CHITS for acute pulmonary embolism since 2019. For the prospective part, it is planned to include patients with same characteristics over the years 2024 and 2025. More than 2,500 patients are expected to be included. This research will have no impact on current patient care. Data from consultations and various examinations carried out as part of care will be collected for six months post-diagnosis in order to meet the research objectives.