Active clinical trials for "Pulmonary Embolism"

To develop a clinical prediction rule to identify patients with acute pulmonary embolism who are at very low risk for short-term adverse outcomes.

Prospective, multicentre, cohort study assessing a diagnostic management strategy for suspected Pulmonary Embolism with independent central adjudication of outcomes

Pulmonary embolism (PE) should be suspected in patients with dyspnea, chest pain, syncope, shock/hypotension, or cardiac arrest. Discriminating patients in different categories of pre-test probability of PE has become a key step in all diagnostic algorithms for PE. The most frequently used clinical prediction rule is the Wells score ("PE likely" > 4 points and "PE unlikely" ≤ 4 points). PE can be safely ruled out in patients with a "PE unlikely" associated with a negative d-dimer test result. Conversely, patients with "PE likely" or positive d-dimer level should undergo further diagnostic testing, like multidetector computed tomography pulmonary angiography (MCTPA). Wells score accuracy is not optimal. Vein and lung US can be rapidly performed at bedside as an extension of physical examination and have a high specificity. The aim of this study is to evaluate if the combination of clinical data reported in the Wells score and US data obtained from vein and lung US (US Wells score) has a better diagnostic accuracy compared to traditional Wells score. In adult patients suspected of PE traditional Wells score will be calculated and vein and lung US (multiorgan US) will be performed in all patients and and US Wells score calculated. The US Wells score differs from the traditional Wells score in the following items: "signs and symptoms of DVT", replaced by "vein US showing DVT", and "alternative diagnosis less likely than PE" replaced by "alternative diagnosis less likely than PE after multiorgan US". This latter item is considered positive if at least one subpleural infarct is detected at lung US, and negative if no subpleural infarcts are detected and an alternative diagnosis like pneumonia, pleural effusion or diffuse interstitial syndrome may explain the symptoms of presentation. If no findings are detected at lung US, the points for the item remain the same assigned by traditional Wells score. Final diagnosis of PE will be preferentially established by MCTPA and in patients discharged without a second level imaging test because of negative Wells or d-dimer, and patients with not conclusive second level diagnostic test, will enter the 3 months follow-up protocol. The diagnostic performance of traditional and US Wells scores will be assessed by calculating sensitivity, specificity, positive, and negative predictive value, and likelihood ratios. Failure rate and efficacy of d-dimer in patients stratified as "PE likely" and "PE unlikely" will also be calculated.

Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.

A multicentre multinational prospective management outcome study has recently proven the safety of a diagnostic strategy combining clinical probability assessment with an age-adjusted D-dimer cut-off, defined as a value of (age x 10) in patients > 50 years, for ruling out PE in outpatients, with a very low likelihood of subsequent symptomatic VTE. Moreover, this study showed that such a strategy increased the diagnostic yield of D-dimers, as it allowed ruling out PE without further investigation in a significantly higher proportion of patients than when using standard cut-off, particularly so in patients 75 years or older. The objective of the present study is to confirm in a prospective cohort of "real life" patients the usefulness of the age-adjusted D-dimer cut-off to rule out PE in patients presenting to the emergency department with suspected PE.

This is a prospective, international, multicenter outcome cohort study. This study starts at the moment patients visit the outpatient clinic 3 to 6 months after a diagnosis of acute PE as part of routine medical care. If patients consent to study participation, the CTEPH clinical prediction score will be calculated. CTEPH is considered to be not present in patients with a low probability (≤6 points) and no symptoms suggestive of CTEPH, i.e. dyspnea on exertion, edema, newly developed palpitations, syncope or chest pains.The remaining patients with either high probability (>6 points) or who report symptoms that may be associated with CTEPH will be subjected to the 'rule-out criteria'. CTEPH will be assumed not present in patients with an age- and gender dependent normal NT-proBNP level (as defined by the assay's manufacturer), in the absence of any of the 3 ECG criteria. Patients who have an abnormal result from the 'rule-out criteria' will be referred for transthoracic echocardiography. All echocardiograms will be performed according to a predefined standardized protocol. In case of echocardiographic intermediate or high probability of PH, patients will be referred for further diagnostic work-up of suspected CTEPH starting with perfusion lung scan or VQ-scan and right heart catheterization, of which the results will be discussed by an independent interdisciplinary working group of PH specialists, to ensure optimal diagnostic management. This latter diagnostic work-up of an abnormal echocardiograph lies within the setting of standard medical care. All patients who were not diagnosed with pulmonary hypertension of any origin, or with NYHA class III or IV heart failure due to left ventricular systolic dysfunction, left ventricular diastolic dysfunction or significant valvular lesions, will be followed for a total of 2 years from the index PE diagnosis. During that period, the study protocol will not interfere with standard patient care, allowing diagnostic tests as deemed indicated by the treating physician including echocardiography in case of new respiratory symptoms. At the end of the follow-up period, all patients will be subjected to a second echocardiography that will be handled according to the above stated procedures to evaluate the presence of CTEPH.

Standardize the approach to outpatient Pulmonary Embolism (PE) and Deep Vein Thrombosis (DVT) treatment.

Based on limited published epidemiological data, up to an alarming 1 in 50 surgical inpatients die within 30 postoperative days. Based on our own data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials, 30-day postoperative mortality among high-risk surgical patients is comparable to this at Barnes-Jewish Hospital, and 1-year mortality among high-risk surgical patients may be as high as 10%. Short- and intermediate-term postoperative mortality is therefore a pressing public health concern. Similarly, postoperative major morbidity - including delirium, stroke, myocardial infarction, atrial fibrillation, blood clots, renal dysfunction, wound infection, pneumonia, respiratory failure, loss of functionality, and chronic pain - occurs commonly and affects a substantial proportion of surgical patients, critically ill patients and patients undergoing procedures for chronic pain. Many factors associate strongly and independently with postoperative mortality and major morbidity: patient age, functional status, comorbid medical conditions, and duration and invasiveness of surgery, among others. It is a strategic priority to identify pre- and intraoperative risk factors that are subject to modification.

EINSTEIN PE study demonstrated that rivaroxaban is at least as effective as the current standard therapy with 51% relative risk reduction of major bleeding (1.1% vs. 2.2%, HR 0.49, 95% CI, 0.31-0.79), in the treatment and secondary prevention of PE. However these patients were required to meet strict eligibility criteria. Little is known about PE treatment in China in routine clinical practice and in a real world study patients at higher or lower risk for adverse events can possibly recruited. Bayer conducts this study to yield post-authorization safety information in rivaroxaban under real-life conditions in China.

At most institutions, the average patient with clinical concern for PE(pulmonary embolism) will have a CT angiogram(CTA) with contrast of the lungs performed to evaluate for a clot. However, CTA has risks including contrast- induced allergic reactions and nephropathy, as well as radiation which has been linked to development of cancer later in life. There is literature that has looked at using lower extremity doppler ultrasound first to evaluate for a DVT (deep venous thrombosis) in patients where there is concern for a PE. There is also literature showing that emergency medicine physicians can perform adequate lower extremity compression ultrasounds (LCUS), at the bedside with results similar to that of the ultrasound tech. The goal of this project is to fuse both principles by having emergency medicine physicians perform LCUS at the bedside, to help reduce CTA utilization in the evaluation of PE.