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Embolism clinical trials

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NCT ID: NCT04032769 Completed - Pulmonary Embolism Clinical Trials

Modified Strategy to Safely Rule Out Pulmonary Embolism in the Emergency Department

MODIGLIA-NI
Start date: October 1, 2019
Phase: N/A
Study type: Interventional

Because a missed PE could be potentially lethal, several researches reported that PE is both overinvestigated and overdiagnosed. The diagnostic gold standard for PE is the computed tomographic pulmonary angiogram (CTPA) and has been shown to have clear risks and other downsides. To limit the use of CTPA, two rules were recently reported to be safe to exclude PE: the PERC rule and the YEARS rule. PERC is an 8 item block of clinical criteria that has recently been validated to safely exclude PE in low risk patients. YEARS is a clinical rule that allow to raise the threshold of D-dimer for the order of CTPA. However, whether a modified diagnostic algorithm that includes these two rules combined could safely reduce imaging study use in the ED is unknown. This is a non-inferiority, cluster cross-over randomized, international trial. Each center will be randomized on the sequence of period intervention: 4 months intervention (MOdified Diagnostic Strategy: MODS) followed by 4 months control (usual care), or 4 months control followed by 4 months intervention with 1 month of "wash-out" between the two periods. All centers will recruit adult emergency patients with a suspicion of PE. In the control group (usual strategy), patients will be tested for D-dimer, followed if positive by a CTPA. In the intervention group (MODS) : All included patients will be tested with quantitative D-dimer. The MODS work-up will be based on YEARS rule : - If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised. If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual.

NCT ID: NCT04022915 Recruiting - Pulmonary Embolism Clinical Trials

PET Fibrin Imaging of DVT and PE

Start date: May 13, 2019
Phase: Phase 1
Study type: Interventional

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).

NCT ID: NCT04020250 Not yet recruiting - Pulmonary Embolism Clinical Trials

Role of Echocardiography in Pulmonary Embolism

Start date: August 2019
Phase:
Study type: Observational

1. To analyze the diagnostic and prognostic value of echocardiographic parameters. 2. Prediction of APE-related 30-day mortality and adverse out comes. 3. The need for rescue thrombolysis in initially normotensive Acute pulmonary embolism (APE) patients.

NCT ID: NCT04018014 Recruiting - Obesity Clinical Trials

Low-dose CT Angiography in the Detection of Acute Pulmonary Embolism: Validation in an Obese Population

Start date: March 21, 2019
Phase:
Study type: Observational

Pulmonary embolism is a common pathology in the general population, whose suspicion is based on the clinical and dosage of D-dimers in particular. The key examination for the diagnosis of pulmonary embolism is chest CT angiography (negative predictive value of 98%). The evolution of machines in recent years allows a reduction of possible kilovoltage up to 80 kV, different computer algorithms (iterative reconstructions) to reconstruct the images and thus reduce the irradiation dose with equal image quality (Evaluation of dose CT and adaptive statistical reconstruction with the same group of patients, Qi et al, 2012; Impact of iterative reconstruction on the diagnosis of acute pulmonary embolism (PE) on reduced-dose chest CT angiograms, Pontana et al , 2015) in patient populations with a weight of less than 100 kilos. However, obesity is a risk factor for pulmonary embolism and the obese population is increasing, thus requiring optimal management regarding irradiation. Few studies have evaluated the quality of low dose CT angiography in obese patients. One study showed the possibility of performing low-dose thoracic CT angiography (100 kV) in patients up to 125 kg, without loss of subjective quality (but with an impact on objective quality), without the use of current iterative reconstruction techniques (Diagnostic confidence and image quality of CT pulmonary angiography at 100 kVp in overweight and obese patients, Megyeri et al, 2015). The study seek to prove that in the obese patient, with a low dose examination (voltage of the tube at 100 kV) and the current iterative reconstructions, the thoracic angioscanner is not less efficient than in the non obese patient, that the qualities objective and subjective analyzes are maintained. The main purpose is to evaluate and compare thoracic CT angiography with weight and BMI, with identical CT parameters (same voltage, computer reconstruction techniques and same contrast injection protocol), by evaluating the objective and subjective diagnostic quality of the opacification of the pulmonary arteries.

NCT ID: NCT04010760 Completed - Pulmonary Embolism Clinical Trials

Non-invasive Diagnosis of Pulmonary Embolism by Use of Biomarkers in Exhaled Breath Condensate

Start date: April 8, 2019
Phase:
Study type: Observational

In this study, a new, non-invasive method for diagnosis of pulmonary embolism (PE) will be tested. In pre-clinical studies, we have identified 151 putative biomarkers for pulmonary embolism in the exhaled breath condensate (EBC). These biomarkers needs validation/consolidation in a clinical setting before further test of this new diagnostic method.

NCT ID: NCT04003116 Completed - Pulmonary Embolism Clinical Trials

Air Versus Oxygen for Intermediate-Risk Pulmonary Embolism (AIRE)

AIRE
Start date: July 11, 2019
Phase: Phase 3
Study type: Interventional

The primary objective is to evaluate the efficacy of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism. The secondary objective is to evaluate the safety of the treatment with supplementary oxygen added to conventional anticoagulant treatment in patients with Intermediate-risk pulmonary embolism.

NCT ID: NCT04001179 Recruiting - Pulmonary Embolism Clinical Trials

Exploratory Metabolomics Study of Exhaled Breath in Pulmonary Embolism

MetabolAir
Start date: December 1, 2021
Phase:
Study type: Observational

Pulmonary embolism is a frequent and recurrent pathology, especially in the elderly. It is often preventable, with high mortality and morbidity, making it a major public health issue. The clinical presentation of pulmonary embolism is non-specific and very highly variable, ranging from asymptomatic thrombus diagnosed incidentally to sudden death. The current diagnosis of pulmonary embolism is based on several diagnostic techniques, mainly non-invasive, which should be used sequentially. We propose to sample the volatile organic compounds using a device that allows them to be trapped on polymer cartridges. Sampling will be performed under monitoring of respiratory pressure and a capnograph to collect alveolar and upper respiratory tract air separately without contamination of the oral cavity or sinuses. This exploratory metabolic analysis will be non-targeted (analysis of all molecules detectable without a priori). The main objective of the study is to identify specific metabolic profiles to predict the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism. Secondary purposes : - To identify metabolic profiles to be used to predict, in combination with clinical probability scores, the results of ventilation-perfusion pulmonary tomoscintigraphy in subjects undergoing this examination for suspected acute pulmonary embolism.; - To correlate metabolic profiles with the topography of embolized lung territories

NCT ID: NCT03999905 Completed - Atrial Fibrillation Clinical Trials

Impact of Pharmacists' Training on Oral Anticoagulant Counseling

Start date: April 24, 2019
Phase: N/A
Study type: Interventional

This study evaluates the impact of community pharmacists' educational training on the nature and adequacy of counseling provided to patients on warfarin, an oral anticoagulant. Half of the community pharmacists participating in the study will receive a two-week educational training on how to adequately counsel patients on warfarin while the other half of community pharmacists will receive the same training after the study. A mystery patient model will be used in this intervention study where six different trained and standardized individuals will act as patients. Each of these mystery patients will supposedly have pulmonary embolism, deep vein thrombosis, or atrial fibrillation. The mystery patient will visit each pharmacy to buy warfarin or complain about adverse drug reaction been experienced. It is expected that pharmacists will provide relevant information and counseling to these patients on the use of the medication warfarin and how to handle the adverse drug reactions.

NCT ID: NCT03988842 Terminated - Pulmonary Embolism Clinical Trials

Standard-dose Apixaban AFtEr Very Low-dose ThromboLYSis for Acute Intermediate-high Risk Acute Pulmonary Embolism

SAFE-LYSE
Start date: July 25, 2019
Phase: Phase 4
Study type: Interventional

The purpose of this study is to examine the degree to which pulmonary embolism (clot) can be dissolved when treated with a very low dose of a systemic thrombolytic drug (clot buster) along with standard anticoagulant therapy as compared to the standard of care anticoagulant therapy alone.

NCT ID: NCT03988231 Withdrawn - Pulmonary Embolism Clinical Trials

Enoxaparin Versus Placebo for Venous Thromboembolism Prevention in Low Risk Cancer Patients After Surgical Procedures: a Randomized, Double Blind, Placebo Controlled Clinical Trial Pilot Study

Start date: July 2021
Phase: Phase 4
Study type: Interventional

Post-surgical bleeding is a major source of morbidity in cancer patients, and ramifications can include need for transfusion, increased length of hospital stay, unexpected return to the operating room, or even death. Current guidelines support that all cancer patients who require surgical procedures receive post-operative blood thinners to minimize risk for blood clots in the legs or lungs, known as venous thromboembolism (VTE), but these medications have an unfavorable risk/benefit relationship among patients at low risk for VTE. The proposed work will pilot a randomized, double blind, placebo controlled trial to critically examine the role of de-implementation of current guidelines that mandate blood thinning medications among cancer patients at low risk for VTE who require surgical procedures; the pilot trial will allow optimization of the design of a future pragmatic multicenter trial, which ultimately would maximize patient safety after surgical procedures for cancer.