30 Clinical Trials for Pulmonary Embolism
The purpose of the ERAsE-PE study is to determine whether two different healthy living strategies (along with anticoagulation) might aid in recovery after a patient is hospitalized for pulmonary embolism. Specifically, Investigators will compare changes in Cardiac Effort (#heart beats used during the 6-minute walk test/walk distance) measured after an 8-week program.
This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).
To evaluate the safety and efficacy of the Cleaner™ Pro Thrombectomy System for aspiration thrombectomy in patients with acute pulmonary embolism (PE).
This is a prospective, multi-center, pivotal study to demonstrate the safety and effectiveness of the Laguna Thrombectomy System for the treatment of pulmonary embolism. The Laguna Thrombectomy System is an investigational device which consists of the Laguna Clot Retriever™ System and the Malibu Aspiration Catheter™ System. These devices are manufactured by Innova Vascular, Inc.
A study of how supplemental oxygen helps patients with acute pulmonary embolism (PE). Hypothesis: Oxygen affects right ventricular dysfunction (RVD) in patients with acute pulmonary embolism (PE) primarily by relieving hypoxic pulmonary vasoconstriction and reducing pulmonary pressure (PA) pressure, and that this process is metabolically driven.
PE-TRACT is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (CDT) and anticoagulation (CDT group) with anticoagulation alone (No-CDT) in 500 patients with submassive PE, proximal pulmonary artery thrombus and right ventricular dilation.
This study is focused on investigating the efficacy and safety of the FlowTriever device to treat low-risk submassive pulmonary embolism.
This study is an observational, prospective study examining the role point-of-care echocardiography of predicting short term adverse outcomes in emergency department patients with acute pulmonary embolism. The primary objective is to assess the diagnostic performance of ultrasound-guided measures of right ventricular dilation (RVD) and strain in predicting clinical outcomes in acute PE. The secondary objective is to investigate the utility of combining ultrasound-guided measures of RVD and the pulmonary embolism severity index (PESI) score in predicting adverse outcomes in acute PE.
The objective of this study is to evaluate real world long-term functional outcomes, safety and performance of the Indigo Aspiration System for the treatment of pulmonary embolism (PE).
There are many available treatments for pulmonary embolism (PE), but the best treatment for this condition is not known. The HI-PEITHO study will compare two treatment options that are both available on the market for the treatment of PE. Patients will be randomized 1:1 to receive either blood thinners (anticoagulation) or blood thinners (anticoagulation) in combination with a device called the EkoSonicTM Endovascular device to dissolve blood clots. Patients will be followed for 12 months after randomization and have assessments while in the hospital as well as at 7 days, 30 days, 6 months and 12 months after randomization. The study will try to find out if one of these treatments is better than the other at reducing the risk of death and other serious problems.
Design: U.S.-based, single-center, proof-of-concept study Brief Description: A standard clinical contrast-enhanced chest CT scan performed 48 hours after clinically-indicated standard anticoagulation will be compared with a standard clinically-indicated baseline contrast-enhanced chest CT scan using a previously-studied and previously-validated 3-dimensional reconstruction technique to assess changes in the pulmonary vasculature in patients with acute pulmonary embolism (PE). This previously-studied and previously-validated 3-dimensional reconstruction technique has been used to assess the response of the pulmonary vasculature to catheter-based fibrinolysis in acute PE as well as to assess the pulmonary vasculature in a number of chronic lung diseases. However, the pulmonary vascular response to standard anticoagulation for acute PE has not been assessed previously. Purpose: To compare the pulmonary vasculature before and after standard clinically-indicated anticoagulation for acute PE using a previously-studied and previously-validated 3-dimensional reconstruction technique applied with a standard clinically-indicated baseline contrast-enhanced chest CT scan (used to diagnose the acute PE) and a standard clinical contrast-enhanced chest CT scan performed 48 hours later as indicated by the study protocol. Population: Inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Enrollment: 10 subjects with acute PE Clinical Site Location: Single-center, Brigham and Women's Hospital Study Duration: 12 months Primary Imaging Outcome: CT-determined percent change in perfusion of the pulmonary vasculature from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital. Secondary Imaging Outcome: CT-determined percent change in right ventricular (RV) volume from baseline to 48 hours in inpatients diagnosed with acute PE, in whom clinical providers have prescribed standard anticoagulation alone for treatment based on clinical grounds at Brigham and Women's Hospital.
The purpose of this study is to develop a unique structure and delivery of home-based exercise through multidisciplinary expertise of cardiovascular medicine specialists and cardiac physiologists using an Interactive Care Plan.
RCT of High-Risk Pulmonary Embolism Comparing FlowTriever System vs. Standard of Care
This study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vertex Pulmonary Embolectomy System in participants presenting with clinical signs and symptoms of acute pulmonary embolism.
This study is a prospective, multicenter, randomized controlled trial of the FlowTriever System plus anticoagulation compared to anticoagulation alone for intermediate-risk acute PE.
Evaluation of initial safety and clinical feasibility of the Hēlo PE Thrombectomy System for thrombectomy in acute submassive pulmonary embolism (PE).
Phase II trial of TS23
This study aims to investigate a novel positron emission tomography(PET)-probe for imaging of fresh intravascular blood clots in pulmonary embolism (PE) and deep venous thrombosis (DVT).
This study is being done to determine the feasibility and safety of using a novel dose adjusted apixaban for the management of participants with cancer-associated venous thromboembolism (blood clot) or and thrombocytopenia (low number of platelets in the blood). Investigators are also looking to see if participants on this treatment have fewer bleeding episodes. The name of the study drug involved in this study is: -Apixiban (a type of anticoagulant)
The purpose of this study is to confirm the safety and efficacy of the ThinkSono Guidance System, a software data collection and communication tool designed to collect ultrasound data to help detect blood clots in veins. The ThinkSono system is CE Mark approved in the European Union and in clinical use in Europe. Usually, when an ultrasound is conducted to diagnose blood clots in veins, a sonographer (trained technologist who conducts ultrasounds) and/or radiologist will conduct the procedure, including a compression ultrasound exam, and the scan may require a bulky cart and ultrasound equipment. The ThinkSono Guidance System is a mobile software application that enables other healthcare professionals such as nurses, non-radiologist physicians including general practitioners, and other allied healthcare professionals to perform the ultrasound at the point of care using guidance from the software app. This is a multi-site non-randomized, double-blinded, prospective cohort pivotal study.
Dynamic digital radiography (DDR) is a new advanced version of chest radiography that captures dynamic images at a rate of 15 frames per second. It is coupled with an analytical software that allows it to provide more advanced measures of lung motion, ventilation, and perfusion compared to traditional chest radiography. While implementation of DDR fixed machines are beginning elsewhere in the US, this trial involves the first applications of an FDA-approved portable DDR machine, for use at the bedside in the ICU. The goal of this clinical trial is to determine the feasibility and safety of portable DDR technology in the ICU, as well as to evaluate the improved clinical diagnostic value of the portable DDR system over current standards of care. Participants will receive one to three sets of DDR images, which will then be compared to their clinical gold standard exams (such as chest x-rays, CTs, or VQ scans) to assess and improve the precision and accuracy of measurements such as diaphragmatic motion, lung movement, and perfusion.
While blood clots after major cancer surgery are common and harmful to patients, the medications to decrease blood clot risk are seldom used after patients leave the hospital despite the recommendation of multiple professional medical societies. The reason why these medications are seldom prescribed is not well understood. The main questions this study aims to answer are: * Does surgeon education paired with an electronic medical record based decision support tool improve the guideline concordant prescription of pharmacologic venous thromboembolism after abdominopelvic cancer surgery? * Does dedicated patient education regarding blood clots at the time of hospital discharge after abdominopelvic cancer surgery improve understanding of the risk of venous thromboembolism and adherence to pharmacologic prophylaxis? The investigators will study these questions using a stepped-wedge randomized trial where groups of surgeons will use a tool integrated to the electronic medical record to educate them on the individualized patient risks of blood clots after major cancer surgery and inform them regarding guidelines for preventative medicines. Utilization of the medications before and after using the tool will be compared. Patients will be administered a questionnaire assessing their awareness of blood clots as a risk after cancer surgery. For those prescribed medications to reduce blood clot risk after leaving the hospital, the questionnaire will evaluate whether they took the medications as prescribed. Survey results will be evaluated before and after implementation of education on blood clot risk at the time of hospital discharge.
Socioeconomically disadvantaged populations with multiple chronic conditions have high rates of nonadherence to essential chronic disease medications after hospital discharge. Medication nonadherence after hospital discharge is significantly associated with increased mortality and higher rates of readmissions and costs among these patients. Major patient-reported barriers to essential medication use after hospital discharge among low-income individuals are related to social determinants of health (SDOH) and include: 1) financial barriers , 2) transportation barriers, and 3) system-level barriers. Although, medication therapy management services are important during care transitions, these services have not proven effective in improving medication adherence after hospital discharge, highlighting a critical need for innovative interventions. The Medication Affordability, Accessibility, and Availability in Care Transitions (Med AAAction) Study will test the effectiveness of a pharmacy-led care transitions intervention versus usual care through a pragmatic randomized controlled trial of 388 Medicaid and uninsured hospital in-patients with MCC from three large healthcare systems in Tennessee. The intervention will involve: 1) medications with zero copay, 2) bedside delivery then home delivery of medications, and 3) care coordination provided by certified pharmacy technicians/health coaches to assist with medication access, medication reconciliation, and rapid and ongoing primary care follow-up. We will examine the impact of the intervention during 12 months on 1) medication adherence (primary outcome) and 2) rapid primary care follow-up, 30-day readmissions, hospitalizations and emergency department visits, and costs. We will conduct key informant interviews to understand patient experience with the acre received during and after care transitions. By examining effectiveness of the intervention on outcomes including medication adherence, health care utilization, costs, and patient experience, this study will provide valuable results to health systems, payers, and policymakers to assist in future implementation and sustainability of the intervention for socioeconomically disadvantaged populations.
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.
The goal of this NIH-sponsored study is to characterize three biomarkers derived from 129Xe gas exchange MRI and to understand how they change in response to interventions.
This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)
This is a Phase 3,multicenter, randomized, open-label, blinded endpoint evaluation study comparing the effect of abelacimab relative to apixaban on venous thromboembolism (VTE) recurrence and bleeding in patients with cancer associated VTE (ASTER)
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Novel coronavirus 2019 (COVID-19) has emerged as a major international public health concern. While much of the morbidity and mortality associated with COVID-19 has been attributed to acute respiratory distress syndrome (ARDS) or end-organ failure, emerging data suggest that disorders of coagulation, in particular hypercoagulability and venous thromboembolism (VTE), may represent an additional major, and possibly preventable, complication (Wu C, et al. JAMA Intern Med. 2020 Mar 13. \[Epub ahead of print\] and Tang N, et al. Thromb. Haemost. 2020 Feb 19. \[EPub Ahead of Print\]). Abnormal coagulation testing results, especially markedly elevated D-dimer and FDP, have been associated with a poor prognosis in COVID-19 infection. We propose the following Electronic Health Record (EHR)-guided 10000-patient, retrospective observational cohort study to assess VTE incidence, risk factors, prevention and management patterns, and thrombotic outcomes in patients with COVID-19 infection. In order to gain the valuable perspective of other regional and national centers providing care for large populations of COVID-19, we have started a collaborative network with 5 additional sites which will provide us with de-identified data from 1000 patients each. These 5000 patients in addition to the 5000-patient cohort we are enrolling within the Mass General Brigham Network will comprise this study population.
The Gonda Vascular Center- Thrombophilia Clinic at Mayo Clinic in Rochester, Minnesota utilizes a standardized, guideline-directed, yet patient-oriented approach for treating patients diagnosed with venous thromboembolism (VTE).This study is the ongoing registry of clinical practice with standardized approach to patient assessment and therapy. As most of registries it does not have any definite number of recruited subjects or the date of study completion but provides anticipated number of recruited subjects and the time of anticipated enrolment which was provided only because of formal requirement related to structure of ClinicalTrials.gov website. This number will be updated and upgraded as we continue this registry. The rates of VTE recurrence, major bleeding, clinically relevant non-major bleeding (CRNMB) and survival in patients treated with anticoagulation for acute VTE are assessed during prospective observation. VTE cases include an acute deep vein thrombosis (DVT) of lower or upper extremities, splanchnic veins, gonadal, renal, cerebral veins thrombosis and pulmonary embolism (PE). Therapy includes the whole spectrum of FDA approved anticoagulants such as "classic" agents: warfarin and heparinoids and the newer direct oral anticoagulants (DOACs) such as rivaroxaban, dabigatran, apixaban, and edoxaban.