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Venous Thromboembolism clinical trials

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NCT ID: NCT03772366 Active, not recruiting - Genital Haemorrhage Clinical Trials

Genital Haemorrhage in Woman of Childbearing Age Treated for Venous Thromboembolism Disease : Comparison According to Oral Anticoagulant and Impact on Quality of Life

GENB-OAB
Start date: June 1, 2019
Phase:
Study type: Observational

Little data are available on the genital haemorrhages in woman of childbearing age treated for venous thromboembolic disease by oral anticoagulant, especially the impact on the quality of life. A recent systematic review in 2016 described for the first time in patients with venous thromboembolic a lower incidence in men of major haemorrhages and minor haemorrhages but clinically significant compared with women (5,3% and 7,9% respectively; RR: 0,635, 95%CI 0,54-0,74 ; p<0,001). It appears that this difference is related to genital haemorrhages and some direct oral anticoagulants are more associated with hemorrhagic surge. In post-hoc analyzes of phases III trials, rivaroxaban was most of the time associated with genital haemorrhages compared to vitamine K antagonists, effect not found with apixaban. Four other retrospective studies seem to find the same conclusions with a higher haemorrhagic risk with the rivaroxaban than with vitamine K antagonist or apixaban. However, haemorrhagic risk is defined in these studies with criteria of severity (anemia, transfusion, use of a health professional, menstrual periods of more than 8 days, inter mentrual bleeding, presence of blood clots) and these studies do not take into account of minor haemorrhages that may affect on the quality of life and asthenia due to anemia. Our objective is : 1- studying the proportion of women with abnormal genital haemorrhages among women of childbearing age treated for venous thromboembolism disease by oral anticoagulant including using a semi quantitative score of menorrhagia. 2- To compare this proportion according to the three molecules of oral anticoagulants (antivitamin K, rivaroxaban and apixaban) and compare the molecules two by two and 3- to evaluate the impact of these haemorrhages on the quality of life. Our study would have a control group of women of childbearing age followed in vascular medicine for superficial venous insufficiency without thrombosis and without oral anticoagulant because the proportion of genital haemorrhages in women of childbearing age in PACA region is not known.

NCT ID: NCT03728166 Recruiting - Clinical trials for Venous Thromboembolism

Computerized Decision Support for Prevention of VTE in Hospitalized Medical Patients Across the Continuum of Care (DC-eALERT)

DC-eALERT
Start date: February 1, 2019
Phase: N/A
Study type: Interventional

Hospitalized medical patients have an increased risk of venous thromboembolism (VTE) across the continuum of care, including after hospital discharge. In the APEX Trial of hospitalized patients with acute medical illness, extended-duration post-discharge thromboprophylaxis with oral betrixaban reduced the frequency of asymptomatic proximal deep venous thrombosis (DVT), symptomatic proximal or distal DVT, symptomatic nonfatal pulmonary embolism (PE), or VTE-related death compared with short-duration enoxaparin. Obstacles to integration of these data in the hospitalized Medical Service patient population, including failure to identify at-risk patients, educational gaps in strategies for VTE prevention after discharge, and medication nonadherence, can be overcome with alert-based computerized decision support. This study is a single-center, 400-patient, randomized controlled trial of an EPIC Best Practice Advisory (BPA; alert-based computerized decision support tool) to increase prescription of extended-duration post-discharge thromboprophylaxis and decrease symptomatic VTE in high-risk patients hospitalized with medical illness. Specific Aim #1: To determine the impact of electronic alert-based CDS (EPIC Best Practice Advisory [BPA]) on prescription of extended-duration post-discharge thromboprophylaxis in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge. Specific Aim #2: To estimate the impact of electronic alert-based CDS (EPIC BPA) on the frequency of symptomatic VTE in high-risk patients hospitalized with medical illness who are not being prescribed any prophylactic anticoagulation for VTE prevention after discharge.

NCT ID: NCT03691753 Recruiting - Clinical trials for Venous Thromboembolism

Safety and Efficacy Study of Fitaya Vena Cava Filter

Start date: September 29, 2018
Phase: N/A
Study type: Interventional

A Multi-center, Randomized Controlled Trial to evaluate the safety and efficacy of Fitaya Vena Cava Filter manufactured by Lifetech Scientific (Shenzhen) Co., LTD. for deep vein thrombosis.

NCT ID: NCT03678506 Terminated - Clinical trials for Venous Thromboembolism

Apixaban for Extended Anticoagulation (APIDULCIS)

APIDULCIS
Start date: August 16, 2018
Phase: Phase 4
Study type: Interventional

The study aims at optimizing the long-term and extended management of patients with a first episode of venous thromboembolism (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients at high risk of recurrence (with altered D-dimer test), who had received anticoagulation (whatever the drug used) for 12-15 months after the first episode of thrombosis, will be treated with Apixaban 2,5 mg x 2 for 18 months as extended treatment. Patients at low risk, with normal D-dimer test, will stop anticoagulation definitely.

NCT ID: NCT03660007 Completed - Pregnancy Clinical Trials

Incidence of Pulmonary and Venous Thromboembolism in IVF Pregnancies After Fresh and Frozen Embryo Transfer

Start date: January 1, 1992
Phase:
Study type: Observational [Patient Registry]

In vitro fertilization (IVF) is associated with an increased risk of venous thromboembolism and in particular pulmonary embolism during the first trimester. It is not known whether this increased risk of pulmonary embolism is present both after fresh and frozen embryo transfer. Objective: To assess whether the risk of pulmonary embolism and venous thromboembolism during the first trimester of IVF pregnancies is associated with both fresh and frozen embryo transfer. A population-based cohort study with linked data from nationwide registries on women in Sweden giving birth to their first child 1992-2012

NCT ID: NCT03659708 Recruiting - Pregnancy Clinical Trials

Pregnancy and Risk of Venous Thromboembolism

PRESCOT
Start date: January 22, 2021
Phase: N/A
Study type: Interventional

The management of venous thromboembolism (VTE) risk in pregnancy still remains a challenge. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians stratify the risk in pregnant women and introduce prophylactic anticoagulation at the appropriate time. Recommendations mostly based on case-control studies and expert opinions do not accurately reflect the physician's need. In view of the lack of international recommendations with a high level of evidence regarding prophylactic treatment of pregnant women at risk of thrombosis, the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and which aids decisions over prophylaxis regimens may help. Investigators have previously described a VTE risk score (the Lyon-VTE-score), rating patients at increased risk of VTE and recommending individually tailored management. A retrospective evaluation of the initial score showed favorable outcomes in pregnancies with a high risk of thrombosis. A subsequent multicenter prospective study reported promising results using this score and related management strategy. The efficacy and safety after 10 years of prospective use of the Lyon-VTE-score in daily practice to guide the prescription of antithrombotic prophylaxis during pregnancy was recently evaluated and the results showed that the Lyon-VTE-score allows a standardized approach with objective criteria and can help non-specialized centers and young doctors manage these high-risk pregnancies. The results of previous studies provide consistent conclusions on the safety and efficacy of the approach of investigators and give background for a medico-economic study to evaluate costs and consequences of this procedure. The most recent study (2005) evaluating the cost of prophylaxis in pregnant women, evaluated this cost as $1292 for each 6-week cycle of treatment. In addition, the use of such a score offers the prospect of personalized medicine, which is probably more cost-efficient compared to "inclusive, equal treatment for all". In antepartum, the decision to administer thromboprophylaxis should be considered on an individual basis with regard to lowering the absolute risk of thrombosis, the inconvenience of daily subcutaneous heparin therapy and the potential risks of bleeding, heparin-induced thrombocytopenia and osteoporosis. An individual assessment of the VTE risk is crucial for optimal thromboprophylaxis, but there is no validated tool to help clinicians to stratify VTE risk in pregnant women and to introduce prophylactic anticoagulation at the right time. Most of the recommendations are grade 2C. They are mostly based on case-control studies and expert opinions and do not entirely highlight the physicians' need. The originality of this approach is the use of a risk stratification tool that takes all individual risk factors for VTE into consideration and that aids the decision-making process of antenatal anti-thrombotic prophylaxis. This study will personalize care using a score to individually assess the risk and propose appropriate prevention. The main objective of this study is to conduct a medico-economic study to evaluate the efficiency of an innovative strategy integrating the Lyon-VTE-score in the management of pregnant patients with venous thromboembolism risk versus standard care.

NCT ID: NCT03646409 Completed - Clinical trials for Venous Thromboembolism

Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

VENETIA
Start date: June 11, 2018
Phase:
Study type: Observational

This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.

NCT ID: NCT03581708 Not yet recruiting - Clinical trials for Venous Thromboembolism

Venous Thromboembolism in Advanced Lung Cancer

RIVAL
Start date: July 2018
Phase:
Study type: Observational

This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.

NCT ID: NCT03580577 Not yet recruiting - Liver Cirrhosis Clinical Trials

Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

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

patient with liver cirrhosis was supposed to have autoanticoagulation which approved to be wrong, with absence of conventional method to detect all abnormalities in coagulation state. Thromboelastography (TEG) give a broad picture for the coagulation defects. In addition to that no guidelines prescribed anticoagulants for venous thromboembolism in cirrhotic, so the investigators will do a study to demonstrate frequency and risk factors for acute venous thromboembolism in cirrhotic patients, find a conventional laboratory method and test TEG to assess risk of thrombosis in cirrhotic patients.Also, to validate current algorithm for use of anticoagulant and antiplatelet for thromboembolism for non cirrhotic in cirrhotic patients.

NCT ID: NCT03563924 Not yet recruiting - Cancer Clinical Trials

Allo - Cancer - Thrombosis

AlloTC
Start date: June 2018
Phase:
Study type: Observational

Management of venous thromboembolism (VTE) in patients with cancer is complex and require the intervention of many specialized health professionals, in hospital but also at home and during follow-up. The AlloTC project aims to integrate the management of VTE within the multidisciplinary care pathway of the patient with cancer, in order to improve the management of VTE in patients with cancer: optimize treatments and follow-up with appropriate anticoagulants, monitor the implementation of good clinical practice, promote patient involvement and adherence. The objective of this monocentric study is to evaluate the efficiency of the integration of the therapeutic management of VTE into a specific management of patient with cancer and to set up a specialized "AlloTC" team that coordinates this course of care. For that purpose, the management of VTE and outcome of patients with cancer and VTE will be compared between two periods : traditional management and management with the "AlloTC" team.