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Embolism clinical trials

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NCT ID: NCT04787120 Not yet recruiting - Pelvic Bleeding Clinical Trials

Squid Liquid Embolic Agent for the Embolization of Abdominopelvic Arterial Bleeding Syndrome (SQUIDperi Study)

SQUIDperi
Start date: April 1, 2021
Phase:
Study type: Observational

Abdominopelvic bleeding can occur due to numerous causes including for the vast majority, trauma, surgery complications and tumors. Interventional radiologists often exclude arterial acute hemorrhage using cyanoacrylate or a liquid embolic agent, but few prospective results have been published to assess their efficacy and safety. The historic and most studied liquid embolic agent to date is Onyx. Results in the treatment of acute peripheral non-neurologic hemorrhage have been detailed in a meta-analysis published in 2015. This systematic review found 19 articles presenting 131 patient cases and 150 lesions treated with Onyx from 2005 to August 2014. There were 11 case series and 8 case reports but no prospective trial. The most common presenting symptoms were of gastrointestinal (GI) origin (n = 51). Rebleeding of the baseline lesion occurred in 7/131 patients. No deaths resulting from complications of the embolic procedure were reported. One patient died of persistent hemoptysis after treatment with Onyx. No deaths were directly attributable to the use of Onyx. During a peripheral embolization procedure with available embolic agents other than SQUIDPERI, residual feedings or collateral vessels became gradually less visible to the operator due to the high radiopacity of the liquid. It was therefore essential to develop an embolization system with lower radiopacity, or with radiopacity that decreases over time. Additionally, depending on the angioarchitecture and flow characteristics, it is important to have an embolic agent with various viscosities. SQUIDPERI is a liquid embolic agent with various viscosities and radiopacities. It is indicated for the embolization of lesions in the peripheral vasculature but its use is poorly reported as of today. The purpose of this prospective non interventional multicenter study is to evaluate the safety and efficacy of SQUIDPERI for the treatment of abdominopelvic arterial acute bleeding or imminent risk of bleeding.

NCT ID: NCT04696913 Not yet recruiting - Covid19 Clinical Trials

Does COVID-19 Infection Increase the Risk of Pulmonary Embolism?

Start date: January 1, 2021
Phase:
Study type: Observational

The World Health Organization (WHO) declared the 2019 novel coronavirus (COVID-19) a pandemic on March 11, 2020. As of 19 July 2020, there have been 14.3 million confirmed cases and over 600,000 confirmed deaths. Up to 14% of infected patients develop interstitial pneumonia, which may evolve to acute respiratory distress syndrome. COVID-19 associated pulmonary arterial microthrombosis and coagulopathy has prompted physicians to implicate pulmonary embolism (PE) as a potential cause for acute respiratory deterioration. Literature review reveals few studies of varying size, quality and design. Recent meta-analysis reports venous thromboembolism in approximately 20% of COVID-19 patients. There has yet to be a case-controlled study which proves and quantifies the associated between COVID-19 and PE.Confirming and quantifying this association has numerous clinical implications for the treatment of critically unwell patients with COVID-19 infection. For example, clinicians will be more inclined to investigate and treat sudden deteriorations with the knowledge that pulmonary embolism is the commonest cause for said deteriorations.

NCT ID: NCT04689451 Not yet recruiting - Pulmonary Embolism Clinical Trials

Feasibility and Safety of Total Percutaneous Closure of Femoral Arterial Access Sites in the Veno-arterial ECMO Patients

Start date: February 1, 2021
Phase:
Study type: Observational

The most frequent access site for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is the common femoral artery (CFA), using either an open or percutaneous technique. Currently, percutaneous closure devices for femoral arterial access sites are approved for use only when a 10-F or smaller sheath has been used. However, the availability of the Perclose ProGlide (Abbott Laboratories, Chicago, IL) device has now made it possible to perform percutaneous vessel closure after using larger sheaths.The preclose technique using Perclose ProGlide, has been widely used in endovascular procedures. In a prospective randomized study, complication rates at the access site were similar in patients who underwent total percutaneous access (including percutaneous arteriotomy closure) than in those who underwent surgical cutdown and subsequent surgical closure. Total percutaneous closure of femoral arterial access sites increases patient comfort and decreases the rate of wound infections and lymphatic fistulas.[6,7] Furthermore, patients are mobilized and discharged earlier following the use of closure devices than with compression alone. Despite the above observations, no data have been published regarding percutaneous closure of femoral artery access sites in patients who have undergone VA-ECMO. In this study, we evaluated the safety and feasibility of a percutaneous closure technique using Perclose ProGlide to close the CFA access site after VA-ECMO.

NCT ID: NCT04609605 Not yet recruiting - Pulmonary Embolism Clinical Trials

Assessment of Right Ventricular Function After Acute Pulmonary Embolism Using Speckle Tracking Echocardiography

Start date: December 2020
Phase: N/A
Study type: Interventional

1. To asses regional RV function in patients presented with acute pulmonary embolism using speckle tracking echocardiography 2. To evaluate its relationship to long term mortality.

NCT ID: NCT04527042 Not yet recruiting - Pulmonary Embolism Clinical Trials

Effectiveness and Safety of Rivaroxaban Used in Extended Anticoagulation for Pulmonary Embolism Patients

Start date: November 30, 2020
Phase:
Study type: Observational

Domestic and international guidelines for the management of pulmonary embolism have suggested that the standard duration of anticoagulation should cover at least 3 months.Whether extended anticogulation therapy shoud balance the efficacy and safety of the therapy.Nevertheless, the concerning about bleeding may affect the decision on the extended anticoagulation for pulmonary embolism patients who may benefit from continuing anticoagulation. Rivaroxaban is an oral direct factor Xa inhibitor, it does not require routine laboratory monitoring and has no food interactions and only a few drug interactions compared to standard of care with the recommendation for the treatment of pulmonary embolism by several guidelines.Our study aims to acquire the data of effectiveness and safety of rivaroxaban used in clinical practice of extended anticoagulation for pulmonary embolism patients in China through this perspective observational study.

NCT ID: NCT04510805 Not yet recruiting - Thrombosis Embolism Clinical Trials

Effectiveness of NextDose for Warfarin Dose Individualization

Start date: August 2020
Phase: Phase 4
Study type: Interventional

Objectives: To understand whether the implementation of warfarin dose management using NextDose (nextdose.org) at The First Affiliated Hospital of Soochow University (Suzhou, China) improves the quality of anticoagulation therapy. Endpoint Primary 1. Percentage of time within the acceptable INR range estimated using linear interpolation during the 28 days after initiation of warfarin. Secondary 2.1 Percentage of Time Measures 2.2 Time to Stable Dose 2.3 Safety Outcomes 2.4 Acceptability of NextDose Recommendations Exploratory 3.1 Percentage of Time Measures 3.2 Time to Stable Dose 3.3 Safety Outcomes 3.4 Acceptability of NextDose Recommendations 3.5 Model Evaluation 3.6 INR Variability Population: 240 participants of any sex between the age of 18 and 80 years. Patients requiring treatment with warfarin following cardiac surgery.

NCT ID: NCT04480892 Not yet recruiting - Clinical trials for Acute Pulmonary Embolism

Fibrinolytic Deficit in Patients With Acute PE

Start date: August 2020
Phase:
Study type: Observational [Patient Registry]

Fibrinolysis is the body's process that prevents blood clots. The investigators hypothesize that patients presenting with acute pulmonary embolism (PE) or blood clots in the lungs differ in their fibrinolytic deficit phenotype. The investigators aim to use biomarkers directly involved in endogenous fibrinolytic cascade including PAI-1, Alpha-2-Antiplasmin (A2A), TAFI, D-dimer, and Fibrinogen to phenotypically characterize patients presenting with acute PE and to correlate these biomarkers with clinical, echocardiographic, computed tomography (CT), and functional status outcomes.

NCT ID: NCT04327960 Not yet recruiting - Pulmonary Embolism Clinical Trials

Risk Assessment Strategies in Pulmonary Embolism

Start date: September 1, 2021
Phase:
Study type: Observational

The aim of this study is to evaluate different scores of risk assessment in patients with pulmonary embolism. This study aim to compare the accuracy of these scores in predicting mortality during hospital admission.

NCT ID: NCT04158973 Not yet recruiting - Pulmonary Embolism Clinical Trials

CHIPs-VTE Study in Hospitalized Patients With Lung Cancer

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

Venous thromboembolism (VTE) is a common complication of malignancies, in particular to lung cancer. Patients with lung cancer in surgical and medical departments are at high risk of VTE development. Prophylaxis is one major way to to prevent it. Currently, VTE prophylaxis is mainly based on VTE-risk assessment. However, all patients hospitalized for cancer are at intermediate or high risk of VTE but their bleeding risk vary. To improve effect of VTE prophylaxis and reduce bleeding events in patients with lung cancer, we will conduct an open-label parallel randomized clinical tria to assess the effect of bleeding risk based prophylaxis strategy among lung cancer patients. We hypothesize that VTE prophylaxis based on bleeding risk assessment with a short post-discharge treatment course is superior to VTE propohylaxis based on VTE risk assessment among hospitalized patients with lung cancer A sample of 3200 eligible patients will be randomized into experimental or control group with an allocation rate of 1:1. Stratified by medical/surgical units, block randomization with a varying block size of 4 or 6 will be adopted to randomize patients into experimental or control group. In experimental group, patients will undergo bleeding risk assessment and receive prophylaxis according to bleeding risk during hospitalization, and they will also receive an extended pharmacological prophylaxis of 5mg Rivaroxaban once daily for up to 15 consecutive days after discharge. In control group, patients will receive routine VTE prophylaxis, VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge. Patients in both groups will be followed up for 30 days. The primary outcome is symptomatic and asymptomatic objectively proven VTE (deep vein thrombosis (DVT) and/or pulmonary embolism (PE)) within 30 days after initiation of randomization. Ultrasound and CTPA will be performed to detect DVT and PE, respectively. Clinically relevant bleeding (non-major clinically relevant and major bleeding, HIT) and death are secondary outcomes.

NCT ID: NCT04110275 Not yet recruiting - Clinical trials for Acute Pulmonary Embolism

Injection of Recombinant Human Tissue-type Plasminogen Activator Derivative for Acute Pulmonary Embolism(rPA)

rPA
Start date: October 2019
Phase: Phase 2
Study type: Interventional

The purpose of this trial is to compare the efficacy and safety of Recombinant Human Tissue-Type Plasminogen Activator Derivative(rPA) and Recombinant Tissue-Type Plasminogen Activator(rt-PA) for the treatment of acute pulmonary embolism. This trial includes two stages, the first stage is to study the dosage of administration of the test drug(rPA), the second is to compare the efficacy and safety of rPA and rt-PA. Both of the two stages are randomized, open and parallel controlled.