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Pulmonary Embolism clinical trials

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NCT ID: NCT06372730 Not yet recruiting - Pulmonary Embolism Clinical Trials

Residual Pulmonary Vascular Obstruction Index Computed With Ventilation/Perfusion SPECT/CT Imaging to Predict the Risk of Venous Thromboembolism Recurrence in Patients With Pulmonary Embolism (PRONOSPECT)

PRONOSPECT
Start date: April 2024
Phase: N/A
Study type: Interventional

Major risk after pulmonary embolism (PE) is recurrence, fatal in 10% of patients. Patients with PE can be stratified in 3 groups according to the risk of recurrence : very low risk, high risk or Intermediate risk. Little is known about this last group. Anticoagulation is efficient to prevent recurrence but is currently not recommended for patient with an intermediate risk of recurrence. Identifying risk factors of recurrent PE remains a major issue to identify sub-groups of patients who would require lifelong anticoagulation. In 30-40% of cases, PE patients develop residual pulmonary vascular obstruction (RPVO), which has been found to be associated with an increased recurrence risk. This last observation was mostly reported in patients with unprovoked PE (patients with high risk of recurrence) and RPVO was measured using conventional planar lung scan. In patients with an intermediate risk of recurrence, the impact of RPVO has been much less studied. In addition, the definition of RPVO was variable according to studies and correlation between RPVO burden and recurrence risk has not been clearly demonstrated. This might be explained by the inherent limitation of RPVO quantification using conventional planar imaging, which is only based on a visual estimation on 2-dimensional images. Ventilation/Perfusion Single Photon Emission Computed Tomography (V/Q SPECT/CT) is a new method of scintigraphic image acquisition that offers the advantage of 3-dimensional imaging, enabling more accurate and reproducible quantification of RPVO. The main hypothesis of this study is that in patients with PE at intermediate risk of recurrence, RPVO computed with V/Q SPECT/CT imaging may be an important predictor of recurrence.

NCT ID: NCT06362928 Not yet recruiting - Clinical trials for Pulmonary Embolism Acute

Safety and Effectiveness of the Akura Thrombectomy System in the Treatment of Acute Pulmonary Embolism

Start date: July 2024
Phase: N/A
Study type: Interventional

This study is a prospective, single-arm, non-randomized, interventional, multicenter feasibility study to evaluate the safety and effectiveness of percutaneous mechanical thrombectomy using the Akura Thrombectomy System in subjects with acute pulmonary embolism (PE).

NCT ID: NCT06362746 Not yet recruiting - Pulmonary Embolism Clinical Trials

Non-immunogenic Recombinant Staphylokinase vs Placebo in Patients With Intermediate High-risk Pulmonary Embolism

Start date: May 15, 2024
Phase: Phase 3
Study type: Interventional

Objective: to evaluate the efficacy and safety of the non-immunogenic recombinant staphylokinase with its single bolus administration in comparison with placebo in normotensive patients with intermediate high-risk pulmonary embolism (PE)

NCT ID: NCT06357403 Not yet recruiting - Pulmonary Embolism Clinical Trials

Association of Anti-factor Xa Activity With Venous Thromboembolism in Critically Ill Patients

AntiXa-ICU
Start date: May 2024
Phase:
Study type: Observational

The goal of this observational study is to analyse the association between anti-factor Xa activity (antiXa) and the occurence of venous thromboembolism (VTE; either deep vein thrombosis and/or pulmonary embolism) in critically ill patients who are admitted to an intensive care unit. The main questions it aims to answer are: - What is the association between antiXa and VTE? - What is the association between antiXa and symptomatic, respectively incidental, VTE? - How is pharmacological anticoagulation with enoxaparin related to measured antiXa? - What is the association between antiXa and bleeding complications. - What is the incidence of venous thromboembolism in patients treated at an intensive care unit? - How is the occurence of VTE related to patient-centred outcomes such as mortality, quality of life, length of stay and days outside of the intensive care unit/hospital.

NCT ID: NCT06312332 Not yet recruiting - Pulmonary Embolism Clinical Trials

Michigan Emergency Department Improvement Collaborative (MEDIC) Alert; Pulmonary Embolism (PE)

Start date: March 2024
Phase: N/A
Study type: Interventional

This study is a quality improvement project to evaluate health care management of pulmonary embolism (PE) patients. The researchers are testing an intervention to determine if it prevents unnecessary hospital admissions.

NCT ID: NCT06310018 Not yet recruiting - Pulmonary Embolism Clinical Trials

Augmented Ultrasound-Facilitated, Catheter-Directed Fibrinolysis for PE

SONIC-PE
Start date: June 30, 2024
Phase: N/A
Study type: Interventional

SONIC-PE is a multicenter, prospective, single-arm study of 10 patients with bilateral PE treated with ultrasound-facilitated, catheter-directed lower-dose fibrinolysis (total dose 8 mg tPA given as 2 mg/hour/catheter over 2 hours) followed by 50 patients (total dose 6 mg tPA given as 3 mg/hour/catheter given over 1 hour) with the EKOS+™ system to determine its impact on the change in RV-to-LV diameter, refined Modified Miller Score, and distal pulmonary vascular blood volume as well as to assess International Society on Thrombosis and Haemostasis (ISTH) major bleeding.

NCT ID: NCT06246045 Not yet recruiting - Clinical trials for Pulmonary Embolism Subacute Massive

Artificial Intelligence to StrategiCally Enhance Pulmonary Embolism Response Team Activation

ASCENT
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Pulmonary embolism (PE) remains a high mortality and morbidity disease state. We have previously shown that use of a Pulmonary Embolism Response Team (PERT) can improve overall readmission, bleeding, and mortality outcomes. Unfortunately, PERT may still be underutilized from a national standpoint and may not be readily available in underserved areas. The utility of the current study is to investigate the implementation of an artificial intelligence (AI) program to differentiate patients at the highest risk of the PE spectrum to help efficiently identify those most appropriate for aggressive management. Furthermore, we will investigate the utility of an algorithm-driven protocol for activation of invasive interventions versus traditional PERT discussion and evaluate overall patient outcomes.

NCT ID: NCT06232551 Not yet recruiting - Clinical trials for Deep Vein Thrombosis

Alerting Providers at Patient Hospital Discharge to Consider Prescribing Rivaroxaban to Reduce Venous Thromboembolism

eVTE
Start date: March 1, 2024
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT06206967 Not yet recruiting - Clinical trials for Pulmonary Thromboembolism

Promotion of Active Lifestyle in Thromboembolism Patients

ACTIVATEP
Start date: January 20, 2024
Phase: N/A
Study type: Interventional

Patients who have suffered a pulmonary thromboembolism used to reduce their activity levels because of the symptoms and the fear to suffer other pulmonary thromboembolism. These patients often have sequelae after the hospitalization that previous studies have associated with a lack of physical activity. The main objective of this research is to investigate the efficacy of a rehabilitation program for promotion higher activity levels in quality of life and self-perceived discapacity of thromboembolism patients.

NCT ID: NCT06195540 Not yet recruiting - Pulmonary Embolism Clinical Trials

RIVAroxaban Versus Low-molecular Weight Heparin in Patients With Lower Limb Trauma Requiring Brace or CASTing

RIVACAST
Start date: May 31, 2024
Phase: Phase 3
Study type: Interventional

Lower limb trauma requiring immobilization is a very frequent condition that is associated with an increased risk of developing venous thromboembolism (VTE). The TRiP(cast) score has been developed to provide individual VTE risk stratification and help in thromboprophylactic anticoagulation decision. The recent CASTING study had confirmed that patients with a TRiP(cast) score <7 have a very low risk of VTE and could be safely manage without prophylactic treatment. Conversely, patients with a score ≥ 7 have a high-risk of VTE and require a prophylactic anticoagulant treatment. Low molecular weight heparins (LMWH) have been shown to be effective in this indication. However, in the CASTING study, the 3-month symptomatic VTE rate was 2.6% in this subgroup despite LMWH prophylactic treatment. This result suggests that LMWH are not sufficiently effective in this particular subgroup of high-risk patients. Direct oral anticoagulants, and in particular rivaroxaban, may be an effective and safe alternative to LMWH. In the PRONOMOS study, comparing LMWH with rivaroxaban in patients who had undergone non-major lower limb surgery, the relative risk of symptomatic VTE was 0.25 (95% CI = 0.09 - 0.75) in favor of rivaroxaban 10mg. No significant increase in bleeding was found. In addition, as LMWH treatment requires subcutaneous daily injections, the use of rivaroxaban may positively impact patients' quality of life as well as being effective in medico-economic terms. The aims of this study are to demonstrate that rivaroxaban is at least as effective, easier to use and more efficient than LMWH in patients with trauma to the lower limb requiring immobilisation and deemed to be at risk of venous thromboembolism (TRiP(cast) score ≥ 7). High-risk patients are randomized to receive either rivaroxaban or LMWH. They are followed up at 45 days and 90 days to assess the occurrence of thrombotic events or bleeding, as well as their satisfaction with the treatment received.