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Venous Thromboembolism clinical trials

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NCT ID: NCT03935451 Recruiting - Ulcerative Colitis Clinical Trials

Postoperative Extended Venous Thromboprophylaxis in Inflammatory Bowel Disease

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Start date: September 1, 2021
Phase: Early Phase 1
Study type: Interventional

Inflammatory bowel disease (IBD) is a relatively common disease that effects all age groups and carries significant morbidity and mortality. The initial treatment typically involves both short and long term medication, however when this is not enough to adequately control the disease, surgery is often required. The high morbidity and mortality rates are in part due to the increased rates of venous thromboembolism (VTE) such as deep vein thrombosis (DVT) or pulmonary embolism (PE) which have been shown to develop more frequently in IBD patients compared to the general population. Undergoing abdominal surgery has also been shown to independently increase rates of DVT and PE and since the majority of patients with IBD will undergo surgery at least once in their lifetime, the relative increased risk of developing a VTE is very high. The majority of DVT and PE events in the postoperative IBD population will occur after discharge from hospital and therefore carries significant morbidity and mortality risk in a unmonitored setting. Several studies have demonstrated the benefits and safety of twice daily dosing of oral extended VTE prophylaxis agents in orthopedic and cancer postoperative patients following discharge from hospital. There have been no randomized studies which have evaluated the use of extended postoperative VTE prophylaxis in IBD patients. The purpose of this randomized placebo controlled pilot trial will be to evaluate the efficacy and safety of postoperative VTE prophylaxis in IBD patients following abdominal surgery. If this pilot trial demonstrates efficacy in reducing postoperative DVT and PE rates, safety and feasibility, clinicians will be armed with the knowledge to pursue a larger multicenter randomized trial with the intent of reducing overall morbidity and mortality in this high risk population.

NCT ID: NCT03919890 Completed - Clinical trials for Venous Thromboembolism

A Two-Part Study to Assess the Safety, Tolerability, PK and PD of ONO-7684 in Healthy Adult Volunteers

Start date: January 17, 2019
Phase: Phase 1
Study type: Interventional

This is a first in human study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of ONO-7684 in healthy adult volunteers. This study will be conducted in 2 parts: Part A is a single-ascending dose and Part B is a multiple-ascending dose.

NCT ID: NCT03881345 Recruiting - Pulmonary Embolism Clinical Trials

Ongoing Registry of Treatment of Venous Thromboembolism

RRT VTE
Start date: April 1, 2019
Phase:
Study type: Observational [Patient Registry]

Ongoing registration of patients with venous thromboembolism treated by means of antithrombotic therapy, thrombolisys, open surgery, endovenous desobstruction and stenting.

NCT ID: NCT03870464 Active, not recruiting - Quality of Life Clinical Trials

LIFE - Lung Cancer, Immunotherapy, Frailty, Effect

Start date: April 1, 2018
Phase:
Study type: Observational

The LIFE study (Lung cancer, Immunotherapy, Frailty, Effect) is investigating the unselected 'real life' non-small cell lung cancer (NSCLC) population treated with immune checkpoint inhibition.

NCT ID: NCT03835780 Completed - Clinical trials for Rheumatoid Arthritis

The Risk of Venous Thromboembolism in Systemic Inflammatory Disorders: a United Kingdom (UK) Matched Cohort Study

Start date: February 1, 2019
Phase:
Study type: Observational

Blood clots occurring in the legs and in the lungs are relatively common; they occur in around 3 in a 1000 people per year. They can cause disability and are also potentially life threatening. When a clot occurs in the legs it is called a deep vein thrombosis or DVT. When they occur in the lungs they are called a pulmonary embolism or PE. The risk for DVT and PE is higher in people with conditions which cause inflammation. The most common of these are inflammatory bowel disease (ulcerative colitis and Crohn's disease), rheumatoid arthritis, and psoriatic arthritis (a condition comprised of psoriasis and joint inflammation). What is not known is how much higher the risk of DVT and PE is in these groups compared with people without inflammatory disease, and what causes the excess risk in these people. This study aims to assess the measure the exact increase in risk for DVT and PE in people with these inflammatory conditions and to identify which risk factors are most strongly associated with the increased risk. These data should help with an understand the causes of blood clot risk in these inflammatory conditions and in identify targets for reducing risk.

NCT ID: NCT03812328 Completed - Clinical trials for Venous Thromboembolism

Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement

COURSE
Start date: February 20, 2019
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to determine if an investigational medication called SelK2 works in preventing a condition called "venous thromboembolism" (VTE) in patients having a total knee replacement. SelK2 has been designed to attach to a protein found on blood cells and blood vessels. By attaching to this protein, SelK2 is designed to decrease the inflammatory process in the blood vessel wall that leads to the formation of blood clots in the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood thinner, it is expected that the risk for bleeding will also be reduced.

NCT ID: NCT03802929 Recruiting - Clinical trials for Venous Thromboembolism (VTE)

Diagnostic and Prognostic Prediction Models for Chinese Patients With Venous Thromboembolism

Start date: June 1, 2019
Phase:
Study type: Observational

The objective of this proposal is to develop and validate diagnostic and prognostic (including short-term and long-term prognoses) prediction models for patients with venous thromboembolism (VTE) in China.

NCT ID: NCT03799016 Completed - Clinical trials for Venous Thromboembolism

An Observational Study on Incidence, Natural History and Treatment Patterns of Venous Thromboembolism in Taiwan

Start date: December 15, 2016
Phase:
Study type: Observational

The research question addressed by this study is primarily on the clinical epidemiology of VTE in Taiwan. The study aims to estimate the incidence of VTE and describe natural history of VTE, including long term clinical outcomes in adult Taiwanese population, utilizing population-based electronic health data in Taiwan.

NCT ID: NCT03781531 Recruiting - Cancer Clinical Trials

Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism

Start date: March 1, 2017
Phase:
Study type: Observational

Venous thromboembolism is a common and serious complication in cancer, and is associated with a substantially increased morbidity and mortality. Furthermore, VTE may be the earliest sign of cancer. Recent studies, however, fail to show a clinical benefit of extended cancer screening in this patient population. Better risk prediction models are therefore warranted to identify VTE patients who would benefit from a rapid and extensive cancer screening. Inflammation and hypercoagulability are considered hallmarks of cancer, and emerging light is being shed on the potential of various markers of inflammation and coagulation in cancer diagnostics and prognostics. Among the inflammatory and thrombotic processes linked to cancer is the neutrophil release of web-like nuclear chromatin (DNA and histones), referred to as neutrophil extracellular traps (NETs). Driven by the tumor environment, NETs have recently been shown to play a central role in tumor progression, metastasis, and tumor-associated thrombosis. The investigators hypothesize that an enhanced inflammatory state may be predictive of an underlying cancer in patients presenting with VTE. The present study is an ongoing prospective study with the primary aim to investigate the diagnostic potential of markers of inflammation, including markers of NETs, in detecting occult cancer in patients presenting with VTE. Secondary aims are to include other biomarkers of cancer, and to assess whether any or a combination of these biomarkers may be prognostic of occult cancer, recurrent thrombotic events, mortality, or cancer disease progression in VTE patients with an underlying malignancy.

NCT ID: NCT03773939 Recruiting - Critical Illness Clinical Trials

Risk Prediction of Venous Thromboembolism in Critically Ill

Start date: March 27, 2015
Phase:
Study type: Observational

Introduction: Venous thromboembolism (VTE), including both deep vein thrombosis and pulmonary embolism, is a frequent cause of morbidity and mortality. The population of critically ill patients is a heterogeneous group of patients with an overall high average risk of developing VTE. No prognostic model has been developed for estimation of this risk specifically in critically ill patients. The aim is to construct and validate a risk assessment model for predicting the risk of in-hospital VTE in critically ill patients. Methods: In the first phase of the study we will create a prognostic model based on a derivation cohort of critically ill patients who were acutely admitted to the intensive care unit. A point-based clinical prediction model will be created using backward stepwise regression analysis from a selection of predefined candidate predictors. Model performance, discrimination and calibration will be evaluated, and the model will be internally validated by bootstrapping. In the second phase of the study, external validation will be performed in an independent cohort, and additionally model performance will be compared with performance of existing VTE risk prediction models derived from, and applied to, general medical patients. Dissemination: This protocol will be published online. The results will be reported according to the Transparent Reporting of multivariate prediction models for Individual Prognosis Or Diagnosis (TRIPOD) statement, and submitted to a peer-reviewed journal for publication.