Active clinical trials for "Pulmonary Embolism"

This multi-center retrospective study collected clinical, laboratory, and CT pulmonary angiography parameters with acute pulmonary embolism patients from admission to predict adverse outcomes within 30 days after admission into hospital.

All calls that end up on the out-of-hours general practitioners' service (OHGPS), which contain a demand for an urgent home visit, are passed on to the on-call general practitioner (GP). These calls are randomized into two arms: after the patient's informed consent, they are assigned either to one arm where the monitoring device, PICO, is applied together with the GP's general care or to the other arm where only the usual care is provided. All data such as suspected diagnosis, treatment or referral, influence of the parameters, ECG and/or alarms on the management and the user-friendliness are recorded. After 30 days, the diagnosis and evolution is requested from the patient's own GP or, if referred to a hospital, in the hospital in order to be able to compare the effect of the approach by the GP between both arms. The aim is to investigate if 1/ the use of the PICO monitoring device could improve GPs' decisions to refer to hospital or not in urgent cases; 2/ there is a difference between the diagnosis with and without the use of the monitoring device using the final diagnosis by the electronic health record of the own GP of the patient; 3/ the call to send a GP for an emergency contained sufficient information for the OHGPS phone operator to take an appropriate decision; 4/ the build-in alarms help the GP during his intervention; 5/ the PICO is easy to use during an emergency; 6/ the use of the device makes them feel more confident in transmitting the information to the Medical Emergency Team.

The purpose of this European Post Market Follow-up Plan is designed to evaluate the safety, efficacy, adverse events and any new information that may surface regarding the use of the AngioJet Ultra PE Thrombectomy Catheter System in patients with thrombus in the main pulmonary and lobar arteries ≥ 6mm in diameter.

Background Patients with cancer and a first deep venous thrombosis of the leg or pulmonary embolism (venous thromboembolism, VTE) are generally treated with low molecular weight heparin (LMWH)injections for 6 months, since this treatment is associated with a reduced incidence of recurrent VTE compared to vitamin K antagonists (VKA). It is recommended that patients with active malignancy (metastatic cancer and/or ongoing cancer treatment)continue anticoagulant treatment. However, it is unknown whether LMWH is still superior compared to VKA for the long-term anticoagulant treatment. Aim The aim of this study is to evaluate whether low-molecular-weight heparin more effectively reduces recurrent VTE compared to vitamin K antagonists in patients with cancer who have already completed 6 to 12 months of anticoagulant treatment because of deep venous thrombosis of the leg or pulmonary embolism. Hypothesis The investigators hypothesize that LMWH is more effective compared to VKA in the long-term treatment of VTE in cancer patients who have already been treated for 6-12 months with anticoagulants. Design This is a multicenter, multinational, randomized, open label trial. Patients Patients with a malignancy (all types, solid and hematological) who have received 6-12 months of anticoagulation for VTE and have an indication for continuing anticoagulation, will be randomly assigned to six additional months of LMWH or VKA. LMWH will be administered in a weight-adjusted scheme, with 65-75% of therapeutic doses. All types of LMWH and VKA are allowed, as long as weight adjusted dosing is possible for LMWH. The target INR will be 2.0-3.0. The primary efficacy outcome is symptomatic recurrent VTE, i.e. deep vein thrombosis and pulmonary embolism. The primary safety outcome is major bleeding. Sample size A total of 65 to 87 recurrent VTE events are needed to show a 50% reduction with LMWH as compared to VKA (type I error 0.05, two-sided, power respectively 80 and 90%). To observe 75 events, with a 10% event rate per half year in the VKA arm and 5% in the LMWH arm a total of 1000 patients will need to be included. Organisation Outcomes will be adjudicated by a central adjudication committee. A steering committee will be formed, preferably consisting of one member of every participating center. An electronic case report form will be used for data collection. Also, an electronic trial master file will be used.

There is a knowledge gap associated with the management of patients with COVID-19 lung injury and a laboratory picture compatible with disseminated intravascular coagulation (DIC). Clinical data to date support that COVID-19 is associated with a prothrombotic state that is not simply explained by an influx of more critically ill individuals. These patients suffer from severe respiratory failure; hypoxemia and ventilator dependence are the primary concerns; ARDS with respiratory failure is frequently the cause of death. Macroscopic and probable microvascular thromboembolic events are a major concern in this population. When DIC is associated with COVID-19, it predicts a very poor prognosis. This study will evaluate the clinical efficacy and safety of low-dose IV bolus tenecteplase (TNK) together with anticoagulation compared with control patients on therapeutic anticoagulation alone in hospitalized adults diagnosed with COVID-19 and acute intermediate-risk PE. Prospective, multicenter, randomized two-arm trial enrolling consecutive patients who meet enrollment criteria. The study will generate evidence that low-dose TNK together with anticoagulation is beneficial in these patients

The trial is an open-label, randomized, trial examining novel biomarkers of thrombosis in patients managed with rivaroxaban vs. standard care following treatment of pulmonary embolism (PE) with catheter-guided alteplase. Patients >18 years old who present with PE and are managed with catheter-guided alteplase will be screened for study inclusion. Patient's meeting inclusion/exclusion criteria will undergo informed consent. Immediately following completion of alteplase infusion, patients will be randomized to receipt of rivaroxaban 15 mg oral bid for 21 days followed by 20mg oral daily or continuation on unfractioned heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3. Blood samples will be taken within 2 hours of CDT completion prior to receipt of study treatment (study day 1), at 8h-12h, 24h, 48h, 5d (or prior to hospital discharge), and at 30 day follow-up. Clinical endpoints, including bleeding, evidence of thrombosis progression, and death will be tracked during index hospitalization and at follow-up 30 days post-discharge.

To assess the efficacy and safety of Tenecteplase versus Placebo in normotensive patients with sub-massive Pulmonary Embolism and Right Ventricular Dysfunction (RVD) all receiving unfractionated heparin (UFH)

Official Title: Compassionate Use of Catheter Thrombectomy (Aspirex 11F) in Patients With Massive Pulmonary Embolism Study Population: Patients >/= 18 years of age with massive pulmonary embolism suitable for mechanical thrombectomy with Aspirex 11F. Treatment: Aspirex 11F assisted thrombectomy _________ The study was terminated early. After having treated seven (7) patients, it was decided in April 2007 that the handling characteristics of the test device should be upgraded before continuing the trial as planned. Therefore, the study was long-term interrupted and finally terminated early. This decision was made by the sponsor in full accordance with the principal investigator. Further studies shall be conducted to show effectiveness and safety of the Aspirex PE catheter thrombectomy device. _________ Primary Endpoints: Thrombectomy with the Aspirex catheter device is associated with an immediate decrease in mean pulmonary artery pressure (PAP) and pulmonary vascular resistance (PVP). The Aspirex thrombectomy catheter does not cause perforation/dissection to treated and untreated cardiovascular structures. Secondary Endpoints: Thrombectomy with the Aspirex catheter device is associated with improved flow in the treated main and lobar pulmonary arteries as assessed by the angiographic Miller index. There will be no significant mechanical haemolysis as assessed by plasma free haemoglobin levels. In-hospital mortality will not exceed 20%. Study Design: A prospective international multicenter non-randomized registry assessing the safety and efficacy of the Aspirex 11F mechanical thrombectomy device. Sample Size: Maximum of 50 patients Inclusion Criteria: Patients with massive pulmonary embolism and cardiogenic shock with failed thrombolysis or at least contraindication for lysis. Exclusion Criteria: Systemic embolism in the presence of an arterial septal defect or patent foramen ovale. Free floating right heart thrombi, left heart thrombi. Life expectancy, due to underlying disease, less than one month.

The OVID study will show whether prophylactic-dose enoxaparin improves survival and reduces unplanned hospitalizations in ambulatory patients aged 50 or older diagnosed with COVID-19, a novel viral disease characterized by severe systemic, pulmonary, and vessel inflammation and coagulation activation.

The purpose of this study is to evaluate the safety and effectiveness of the LUMIFI with Crux VCF System for deployment of the Crux VCF. The study will compare the method of Crux VCF deployment using the LUMIFI with Crux VCF System (IVUS guidance) with the historical results of the Crux VCF System (fluoroscopic guidance). The study will include enrollment into a roll in phase consisting of 2 study subjects per site prior to enrollment into the primary treatment phase for primary analyses. The purpose of the roll in phase is to assure compliance with site training on the use of the investigational device and protocol workflow.