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Pulmonary Embolism clinical trials

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NCT ID: NCT04889261 Recruiting - Pulmonary Embolism Clinical Trials

External Validation of the CHOD Risk Scale

CHOD-1
Start date: May 17, 2021
Phase:
Study type: Observational

Severe COVID-19 is associated with a hypercoagulable state, with a high risk of thrombotic phenomena such as pulmonary thromboembolism (PE). Its diagnostic suspicion is complicated, due to the overlap of symptoms of PE with those of COVID-19 itself. Therefore, it is essential to improve PE prediction to optimise the performance of confirmatory imaging tests such as thoracic CT angiography. Early diagnosis has relevant therapeutic implications, as it justifies starting anticoagulant treatment early, with a possible positive impact on the clinical evolution of these patients. The CHOD risk scale has recently been described: the acronym for C-reactive protein concentration, heart rate, oxygen saturation, and D-Dimer levels. Its initial description was carried out in a study in a single hospital centre. proving to be an easy-to-apply tool, useful for predicting the appearance of PE in patients hospitalized for COVID-19. The objective of this study is to carry out an external validation of this scale in patients hospitalized for COVID-19 pneumonia, through an observational, cross-sectional, multicenter, real-life study in patients hospitalized for severe COVID-19 pneumonia, confirmed by objective methods, and showing high D-dimer values. Imaging tests with CT angiography will be performed in patients with elevated D-Dimer, following international clinical practice regulations. Given that they will be consecutive patients, CT angiography will be performed in all patients regardless of the patient's clinical probability of PE as long as they meet the inclusion criteria and none of the exclusion criteria. To calculate the PE predictive power of the CHOD scale in the validation cohort, a methodology similar to that used in the construction cohort will be used, that is, the use of a ROC curve. Taking into account that a similar predictive value (with a maximum error of 5%) between the CHOD scale in the construction cohort and that of this study (validation cohort) will be considered as an adequate external validation, and taking into account a statistical power of 80%, an alpha error of 5% and a maximum loss of patients of 15%, the required sample size is 245 patients. Since 7 centres initially participate, each of which will have to contribute 35 valid consecutive patients for the analysis.

NCT ID: NCT04879069 Recruiting - Clinical trials for Pulmonary Embolism With Acute Cor Pulmonale

Polish Multicenter PERTs PE Outcomes Registry

PolPERTs
Start date: June 1, 2018
Phase:
Study type: Observational

Pulmonary embolism (PE) is the third leading cause of cardiovascular mortality. The Pulmonary Embolism Response Team (PERT) concept offers a rapid and multidisciplinary approach focused on improving outcomes for patients with PE. All institutionalized PERTs in Poland have been invited to join the study. The goal of this registry is to describe current practice and outcomes in patients with acute PE treated by Polish PERTs.

NCT ID: NCT04859478 Recruiting - Clinical trials for Pulmonary Embolus/Emboli

Venous Phase Dual Energy CT in Patients Suspected for Pulmonary Embolism.

Start date: January 1, 2021
Phase: N/A
Study type: Interventional

Venous phase spectral or dual energy (DE) chest computed tomography (CT) in patients with suspected pulmonary embolism (PE) compared to standard computed tomography pulmonary angiography (CTPA): sensitivity, evaluation of iodine mapping and incidental findings.

NCT ID: NCT04798261 Recruiting - Pulmonary Embolism Clinical Trials

Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System

Start date: June 25, 2021
Phase:
Study type: Observational

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).

NCT ID: NCT04790370 Recruiting - Pulmonary Embolism Clinical Trials

Ultrasound-facilitated, Catheter-directed, Thrombolysis in Intermediate-high Risk Pulmonary Embolism

HI-PEITHO
Start date: August 2, 2021
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT04757129 Recruiting - Clinical trials for Acute Pulmonary Embolism

Changes of Cardiopulmonary Function After Thrombolysis in Patients With Pulmonary Embolism

CCFATAPE
Start date: January 1, 2020
Phase:
Study type: Observational

The investigators expect to enroll about 80-100 acute pulmonary embolism patients treated with thrombolysis in two hospitals. Dynamic changes of cardiopulmonary function after thrombolysis are detected to evaluate which indicators can quickly reflect the effectiveness of thrombolysis.

NCT ID: NCT04731558 Recruiting - Surgery Clinical Trials

Pre- vs Postoperative Thromboprophylaxis for Liver Resection

PREPOSTEROUS
Start date: February 10, 2021
Phase: Phase 4
Study type: Interventional

Thromboprophylaxis for liver surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in liver surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing liver surgery. As far as we know, there are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with liver surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Traditionally, many liver surgery units have been reluctant in using preoperative thromboprophylaxis due to the potentially increased risk of bleeding complications. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in liver surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in liver surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in liver surgery in a randomized controlled trial.

NCT ID: NCT04727437 Recruiting - Clinical trials for Subsegmental Pulmonary Embolism Nos

STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism

STOPAPE
Start date: April 8, 2021
Phase: Phase 3
Study type: Interventional

Pulmonary embolisms (PE) occur when blood clots cause a blockage of the blood supply to the lungs. A small PE located in the subsegmental pulmonary vasculature is identified as a subsegmental PE (SSPE). Anticoagulants are used to treat SSPE and work by preventing new clots from forming whilst the body's own mechanisms break down the clots, however they can also increase the risk of major and potentially life threatening bleeding. More recent observational data of routine care for SSPE showed very high complication rates of anticoagulation but in patients where treatment was withheld, this proved to be a safe strategy in terms of recurrent venous thromboembolism (VTE). Computed tomography pulmonary angiography (CTPA) scans are now able to detect SSPE, however there are concerns that there is an over-diagnosis due to the incorrect interpretation of small artefacts. 1466 patients from approximately 50 sites will be recruited, these sites will consist of hospitals across the United Kingdom (UK). Patients 18 and over with isolated SSPE, confirmed by either CTPA or CT thorax with IV contrast, will be eligible for the trial. Patients will be randomised to either receive standard anticoagulation for at least 3 months (control) or no anticoagulation for at least 3 months (intervention). The participant will receive telephone follow up calls at 4, 12 and 24 weeks following the end of their treatment, and additional data will also be taken from their medical records at these time points. The participant isn't required to be contacted for the 52 week follow up as the data will be extracted from the National Health Service (NHS) Digital collection of Hospital Episode Statistics (HES). In total participation in the study will last 12 months. In addition the cost-effectiveness of no treatment versus treatment with full anticoagulation will be looked at and also improving on radiological diagnosis of SSPE.

NCT ID: NCT04711746 Recruiting - Pulmonary Embolism Clinical Trials

Is Clonal Hematopoiesis of Indeterminate Potential Associated With Unprovoked Pulmonary Embolism?

HEMEP
Start date: February 1, 2021
Phase: N/A
Study type: Interventional

The clonal hematopoiesis of indetermined prognosis (CHIP) has been described as risk factor for juvenile atherosclerosis. Moreover, some of CHIP genes are responsible of myeloproliferative disorders. Venous thrombosis are frequent in these disorders. The purpose of this project is to determine if CHIP is frequent in unprovoked pulmonary embolism and could be part of the pathophysiology.

NCT ID: NCT04674202 Recruiting - Atrial Fibrillation Clinical Trials

Pilot Study: Comparison of Patients' Knowledge of Direct Oral Anticoagulants in Post-hospitalization Between 2 Cardiology Departments Offering or Not a Pharmaceutical Interview During Hospitalization

EDUC-AOD
Start date: January 18, 2021
Phase:
Study type: Observational

Direct oral anticoagulants (Rivaroxaban, Apixaban and Dabigatran) are an alternative to anti-vitamin K drugs and low molecular weight heparins in many cardiovascular diseases. This new class of anticoagulants represents a particular and very promising advance: they are administered orally, their mechanism of action is rapid and direct on coagulation and their predictable pharmacological action allows for administration at fixed doses. In contrast to anti-vitamin K, there is no need for routine biological monitoring. However, their therapeutic range is narrow and there is no routine biological monitoring. Rigorous compliance is therefore necessary. In addition, there are no official validated recommendations either for the measurement of anticoagulant activity in certain emergency situations, or for the management of severe bleeding (except recently for Pradaxa®). Their correct use requires the training and involvement of health professionals as well as information and support for patients. Pharmaceutical interviews are one of the main ways in which pharmacists can ensure this security through personalized and optimal patient care. The purpose of these interviews is to: - Reinforce the pharmacist's advisory, educational and preventive roles with patients; - To enhance the pharmacist's expertise in the area of medication; - To evaluate the patient's knowledge of his or her treatment; - To assess the patient's knowledge of his or her treatment; To seek the patient's therapeutic adherence and help him or her to take ownership of his or her treatment; - To evaluate, in the long term, the patient's appropriation of his or her treatment. In this way, they enable involvement with patients while providing a link between healthcare professionals, which is essential for optimal patient care. In recent years, numerous studies have been conducted on pharmaceutical interviews in the United Kingdom and the Netherlands. On the other hand, few studies have been conducted in France to evaluate the clinical impact of pharmaceutical interviewing in medical services. The aim of this study is to compare patients' knowledge of direct oral anticoagulants between 2 cardiology departments offering or not a pharmaceutical interview.