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Thromboembolism clinical trials

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NCT ID: NCT04616846 Completed - Covid19 Clinical Trials

Thromboembolic Risk Screening in Patients With Cancer and COVID-19

NEOTHROCOVID
Start date: August 4, 2020
Phase: N/A
Study type: Interventional

Study Rational Since December 2019, outbreak of COVID-19 caused by a novel virus SARS-Cov-2 has spread rapidly around the world and became a pandemic issue. First data report high mortality in severe patients with 30% death rate at 28 days. Exact proportions of the reasons of death are unclear: severe respiratory distress syndrome is mainly reported which can be related to massive cell destruction by the virus, bacterial surinfection, cardiomyopathy or pulmonary embolism. The exact proportion of all these causes is unknown and venous thromboembolism could be a major cause because of the massive inflammation reported during COVID-19. High levels of D-dimers and fibrin degradation products are associated with increased risk of mortality and some authors suggest a possible occurrence of venous thromboembolism (VTE) during COVID-19. Indeed, COVID-19 infected patients are likely at increased risk of VTE. In a multicenter retrospective cohort study from China, elevated D-dimers levels (>1g/L) were strongly associated with in-hospital death, even after multivariable adjustment. Also, interestingly,the prophylactic administration of anticoagulant treatment was associated with decreased mortality in a cohort of 449 patients, with a positive effect in patients with coagulopathy (sepsis-induced coagulopathy score ≥ 4) reducing the 28 days mortality rate (32.8% versus 52.4%, p=0.01). However the presence/prevalence of VTE disease is unknown in COVID-19 cancer patients with either mild or severe disease. Cancer patients are at a higher risk of VTE than general population (x6 times) and could be consequently at a further higher of VTE during COVID-19, in comparison with non-cancer patients. The exact rate of VTE and pulmonary embolism during COVID-19 was never evaluated, especially in cancer patients, and is of importance in order to understand if this disease needs appropriate prophylaxis against VTE. The largest series of cancer patients so far included 28 COVID-19 infected cancer patients: the rate of mortality was 28.6%. 78.6% of them needed oxygen therapy, 35.7% of them mechanical ventilation. Pulmonary embolism was suspected in some patients but not investigated due to the severity of the disease and renal insufficiency, reflecting the lack of data in this situation. The aim of the present study is to analyze the rate of symptomatic/occult VTE in a cohort of patients with cancer. Expected benefits Anticipated benefits of the research are the detection of VTE in order to treat it for the included patient. For all COVID-19 positive cancer patients it will enable to provide some guidelines and determine which patient are at risk for VTE and which will need ultrasound to detect occult VTE. Foreseeable risks Foreseeable risks for patients are non-significant because the additional procedures needed are ultrasound exam, and blood sample test. Methodology Retrospective and prospective (ambispective), multicentric study to evaluate the occurrence of venous thromboembolism during COVID-19 infection. Indeed, because the outbreak can end within the next 3-6 months, Investigators may not be able to answer the question if Investigators only focus on patients investigated prospectively. Investigators then decided to include patients from medical team who are already systemically screening patients with COVID-19 disease for VTE. Trial objectives Main objective To evaluate the rate of venous thromboembolism at 23 days during COVID-19 infection in cancer patients.

NCT ID: NCT04593654 Completed - Covid19 Clinical Trials

Dosing of Thromboprophylaxis and Mortality in Critically Ill COVID-19 Patients

Start date: March 1, 2020
Phase:
Study type: Observational

The aim of the study is to associate dose of thromboprophylaxis with outcome in critically ill COVID-19 patients. This will be done by associating dose of thromboprophylaxis with 28-day mortality, survival outside ICU, thromboembolic event and bleeding complications.This was done in our earlier study for patients admitted in March and April (Clinicaltrials.gov NCT04412304 June 2 2020) but now we will include the patients admitted in May, June and half of July and we will ad the outcome of 90-day mortality.

NCT ID: NCT04574895 Completed - Pulmonary Embolism Clinical Trials

Using a Real-Time Risk Prediction Model to Predict Pediatric Venous Thromboembolism (VTE) Events

Start date: November 2, 2020
Phase: N/A
Study type: Interventional

The study will evaluate the effectiveness of a novel, real-time risk prediction model for identifying pediatric patients at risk for developing in-hospital blood clots (or venous thromboembolism [VTE]) based on data easily extracted from the electronic medical record. The study will assess whether using the risk percentages for developing VTE derived from the model increases the number of high-risk patients screened by the pediatric hematology team, which may may lead to an overall reduction in the number of pediatric VTEs seen at Monroe Carell Jr. Children's Hospital at Vanderbilt.

NCT ID: NCT04569344 Completed - Covid19 Clinical Trials

COVID-19 and Venous Thromboembolism Risk

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

Coronavirus disease 2019 (Covid-19) is now a leading cause of death among U.S. adults. In addition to profound respiratory and multi-organ failure, hypercoagulable states and venous thromboembolism (VTE) have been increasingly reported in patients with severe Covid-19. The aim of this study is evaluate the risk of VTE related to Covid-19 infection in a real-world community-based population.

NCT ID: NCT04567927 Completed - SARS Virus Clinical Trials

Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19

Start date: March 3, 2020
Phase:
Study type: Observational

The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

NCT ID: NCT04523220 Completed - Hemodialysis Clinical Trials

Study to Investigate the Safety of a Drug Called Osocimab at Low and High Doses in Adult Patients With Kidney Failure Requiring Regular Hemodialysis

CONVERT
Start date: August 28, 2020
Phase: Phase 2
Study type: Interventional

In this study researchers want to learn about the safety of drug Osocimab at lower-dose and higher-doses in adult participants with kidney disease undergoing regular dialysis (a procedure that uses a machine to get rid of toxins and extra fluids in the blood). Patients with kidney disease undergoing regular dialysis are at high risk for heart and blood vessels diseases. Osocimab is a human monoclonal antibody under development for the prevention of events caused by blood clots like heart attack, stroke and death due to heart or blood vessels diseases. It works by binding to and blocking the activated form of clotting factor XI which increases the formation and stability of clots. Researchers also want to find out how drug Osocimab works in human body and how the body absorbs, distributes and excretes the drug. Participants in this study will receive monthly injection of either Osocimab at a lower-dose or higher-dose or placebo (a placebo looks like a treatment but does not have any medicine in it). Both Osocimab and placebo will be injected into the tissue under the skin of the belly. Observation for each participant will last up to 23 months. Blood samples will be collected from the participants to monitor the safety and measure the blood level of the study drug.

NCT ID: NCT04510987 Completed - Clinical trials for Prevention of Thromboembolic Events

Study to Assess the Safety, Tolerability, Effects on the Body, Absorption, Distribution and Elimination of 25 mg BAY2433334 in Renal Impairment Including Renal Replacement Therapy ("Dialysis")

Start date: August 12, 2020
Phase: Phase 1
Study type: Interventional

BAY2433334 is under clinical development for prevention of complications in diseases such as heart attack, irregular heart beat or stroke which can arise by formation of blood clots elsewhere in the body and travels through the blood stream to plug another vessel. Renal impairment which co-occurs in elderly and patients with heart attack, irregular heart beat or stroke is a common condition in which the kidneys are not filtering the blood as well as they should. The goal of the study is to learn more about the safety of BAY2433334, how it is tolerated and the way the body absorbs, distributes and gets rid of the study dug given as a single oral dose of 25 mg tablet in participants with renal impairment and healthy participants matched for age-, gender-, and weight.

NCT ID: NCT04499612 Completed - Thromboembolism Clinical Trials

Influence of Cardiac Implantable Electronic Devices on the Hemostatic System

Start date: March 1, 2020
Phase:
Study type: Observational

The hemostasis system is one of the many biological systems of the human body, designed to preserve the liquid state of blood and prevent its loss during vascular injuries. The ideal balance between its coagulant and anticoagulant components never occurs. In various diseases and pathological conditions, the balance of the hemostasis system may be disturbed. Shifts towards hypercoagulability lead to the development of hemorrhagic complications, opposite shifts lead to the development of thrombotic complications. Patients with cardiac implantable electronic devices (CIED) are not rare and unique, today doctors meet with them every day. Its more than 1.5 million CIED's implanted every year. Before surgery these patients are standard cardiology department patients with chronic heart failure (CHF), which develops due to the presence of arrhythmias, coronary heart disease, hypertension, congenital heart disease, myocardial infarction, myocarditis or other diseases and conditions. CHF is the most common, severe and unfavorable prognostic complication of these diseases. With CHF, the balance of the hemostasis system shifts towards hypercoagulation. Patients with CHF have an increased risk of arterial and venous thrombosis, pulmonary embolism, myocardial infarction, stroke, numerous brady- and tachyarrhythmias and other complications. After CIED implantation, bradyarrhythmia is eliminated, as one of the parts in the pathogenesis of CHF. Patients, especially those with severe symptoms, improve their condition in the early postoperative period. In the long-term period, pacing, on the contrary, may contribute to the progression of CHF. The wrong choice of pacing mode or the place of electrode implantation can lead to desynchronization of the heart chambers, myocardial remodeling and left ventricular dysfunction. Uncertainty is also observed in relation to the hemostasis system after CIED implantation. On the one hand, correction of bradyarrhythmia and CHF should provide patients with a shift towards hypocoagulability by normalizing the heart rate. On the other hand, trauma to the vessel wall during surgery, further placement of the CIED leads in the vessels, and perioperative stress can lead to even greater shifts towards hypercoagulation.

NCT ID: NCT04479579 Completed - Surgery Clinical Trials

Improved Adherence With Extended Venous Thromboembolism Prophylaxis After Major Cancer Surgery

Start date: February 22, 2021
Phase: Phase 4
Study type: Interventional

This is a prospective, twin-center, cohort study in patients discharged from the hospital after major abdominal or pelvic cancer surgery for cancer. This study is designed to evaluate the adherence to extended deep vein thrombosis prophylaxis (DVT) with the direct oral anticoagulant apixaban on the background of historical data from the investigator's center on low-molecular-weight heparin (LMWH) substandard adherence in the same setting.

NCT ID: NCT04477564 Completed - Clinical trials for Venous Thromboembolism

Clonal Hematopoiesis of Indeterminate Potential in Venous Thromboembolism

CHIPS
Start date: July 3, 2020
Phase:
Study type: Observational

The aim of the study is to investigate the existence of clonal hematopoiesis of indeterminate potential (CHIP) in patients with a history of venous thromboembolism. The study investigators make the assumption that these patients present mutations involved in CHIP occurrence.