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Venous Thromboembolic Disease clinical trials

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NCT ID: NCT05993533 Recruiting - Clinical trials for Venous Thromboembolic Disease

Comparison of the 'CTR' Ratio With Standard Haemostasis Parameters in the Follow-up of Patients Undergoing Heparin Therapy

QuantiXa
Start date: June 22, 2023
Phase:
Study type: Observational

The Quantra(r) hemostasis analyzer (Stago) is a recent addition to the family of global hemostasis tests. It uses ultrasound-based technology to characterize the viscoelastic properties of a whole blood sample during coagulation. The Qplus(r) cartridge consists of independent channels, each containing different reagents that provide parallel measurements of 6 parameters. This global test takes into account cellular elements such as platelets and red blood cells in clot formation, and also explores fibrinolysis. In addition, this test is of particular interest in delocalized biology, i.e. at the patient's bedside, and avoids the time-consuming laboratory centrifugation stage required for routine analyzers. In practice, this test has been developed to monitor haemostasis in patients who may present with a range of coagulopathies of various etiologies, but also in the management of haemorrhagic patients, in order to adapt the administration of blood products in particular. The Quantra (r) analyzer could therefore be of interest since it could be deployed in overseas operations to manage war casualties. Recent studies (EACTAIC-ICCVA congress, October 2021) have shown that there is a good correlation between anti-Xa activity and the CTR (coagulation time ratio) parameter of the Quantra cartridge Qplus (TM), suggesting that this automated system could be used to manage anticoagulant therapy.

NCT ID: NCT05627375 Recruiting - Clinical trials for Venous Thromboembolic Disease

Best Antithrombotic Therapy in Patients With Acute Venous ThromboEmbolism While Taking Antiplatelets

BAT-VTE
Start date: August 16, 2023
Phase: Phase 3
Study type: Interventional

Venous thromboembolism (VTE) and atherosclerotic cardiovascular disease share common risk factors and frequently coexist in the same patients. Their management requires use of antithrombotic agents: anticoagulant therapy (AC) for secondary prevention of VTE recurrence, antiplatelet (AP) for secondary prevention of major adverse ischemic cardiovascular and cerebrovascular event (MACCE) in patients with atherosclerotic cardiovascular disease (coronary artery disease, atherosclerotic cerebrovascular disease, lower extremity peripheral arterial disease). Side effects of antithrombotic drugs are the 1st cause of emergency admission and hospitalization for an adverse drug reaction (mainly bleeding), and the combination of AC with AP strongly increases this risk.

NCT ID: NCT05150314 Recruiting - Clinical trials for Venous Thromboembolic Disease

Comparative Study of the Hemorrhagic Risk in Patients Over 75 Years of Age Taking Enoxaparin

ENOX-VTD-H
Start date: November 18, 2021
Phase:
Study type: Observational

Elderly subjects are at greater risk of thrombophlebitis than the general population, but also of bleeding when anticoagulant therapy is initiated. Enoxaparin is one of the most widely used anticoagulants in the management of venous thromboembolism in the world. Its use is not codified in the elderly, because too few studies have been carried out in people over 75 years old. For several years, Enoxaparin in curative treatment has been administered at a reduced dosage of 4000 IU twice a day (and not at a standard dose of 100 IU / kg) at the Geriatrics center of the CRHU in Strasbourg with the clinical impression of a reduction the risk of serious bleeding without reduction in therapeutic efficacy in this very elderly population. Confirmation of a reduction in the risk of bleeding at this dosage could be the start of a change in prescribing practices, towards a more suitable dosage in the elderly.

NCT ID: NCT05089227 Recruiting - Clinical trials for Autoimmune Hemolytic Anemia

Efficacy of Prolonged Anticoagulation for Primary Prevention of Venous Thromboembolic Disease in Autoimmune Hemolytic Anemia: a Prospective, Phase II, Randomized, Multicenter Study

API-AHAI
Start date: February 3, 2022
Phase: Phase 2
Study type: Interventional

Autoimmune hemolytic anemia (AIHA) is a rare autoimmune disease (incidence <1/100,000 population) responsible for the destruction of red blood cells by the host immune system, notably through the action of autoantibodies. Apart from complications related to anemia, the occurrence of venous thromboembolism (VTE) in this population is frequent, estimated at 20-27%. The risk of VTE is highest during the period of hemolysis, especially during the first 3 months after the diagnosis of AIHA. This risk is 7.5 [4.7; 12.0] times greater than in the general population. No clinical predictive factor for VTE was identified and the usual factors (cancer, previous VTE, bed rest >3 days, surgery, age >70 years, heart or respiratory failure, myocardial infarction, stroke, obesity, hormone replacement therapy) were not considered. Several biological risk factors have been suggested (depth of anemia, bilirubin level, leukocyte count, antiphospholipid antibodies) but have not been confirmed in other studies. AIHA is therefore a risk factor for VTE in its own right, and the National Diagnostic and Care Protocol (NDCP) recommends the implementation of VTE prevention during acute hemolysis (Grade C). However, the value of this prophylaxis has never been prospectively evaluated and its duration is empirical. In practice, low-molecular-weight heparin (LMWH) is generally used during "flare-ups" of AIHA (diagnosis and relapse) in hospitalized patients, but is rarely continued beyond the hospital phase when VTE also occurs in ambulatory patients. Thus, we hypothesize that prolonged preventive anticoagulation during the 12-week risk period following diagnosis or relapse of AIHA could decrease the incidence of VTE. In orthopedic surgery, this strategy has been proven to decrease VTE from 50% to 10-15%. In certain high-risk medical situations, prolonged prophylaxis with apixaban has been shown to decrease the occurrence of VTE from 10.2% to 4.2% in solid cancers4 and from 4-11% to 2% in myeloma.

NCT ID: NCT04211181 Recruiting - Pulmonary Embolism Clinical Trials

CHIPs-VTE Study in Hospitalized Patients to Prevent Hospital-Acquired Venous Thromboembolism

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Although pharmacologic and mechanical methods to prevent VTE are safe, effective, cost-effective, and advocated by authoritative guidelines,many studies continue to demonstrate that these preventive methods are significantly underutilized, especially in China.A number of quality improvements (QI) program have been established in several countries or hospitals.However,no exit effective protocol has been demonstrated well enough or adequate to drive breakthrough levels of improvement. A reliable and practical QI that can support hospitals or physicians in China is warranted.To evaluate the multifaceted quality improvement intervention effect in clinical setting, we will conduct a cluster-randomized clinical trial among China PUlmonary Thromboembolism REgistry Study (CURES) group, aiming to test whether it's applicable to real-world practice in China. A multicenter, two-arms, open-label clinical trial has been designed to determine whether the system-wide multifaceted intervention could increase the rate of at-risk participants who received prophylaxis (RP) and decrease the incidence of any hospital-associated VTE in 90 days during and after hospital admission. .Selected hospital will be regarded as a cluster and randomized into interventional or control group.In interventional group, eligible hospitalized patients will receive a variety of the multifaceted quality improvement(QI) interventions since admitted in hospital.In control group, patients will receive no more than common recommended care or an existing policy.The primary outcomes are the proportion of appropriate prophylaxis in hospitalized patients and the incidence of HA-VTE in 90 days after hospital admission.

NCT ID: NCT04007653 Recruiting - Quality of Life Clinical Trials

Long-term Outcome After Edoxaban Versus Vitamin K Antagonists for Acute VTE

HOKUSAIpostVTE
Start date: April 25, 2017
Phase:
Study type: Observational

The HOKUSAI post VTE study contains of two different research questions; one on the long term outcomes of deep vein thrombosis and one on the long term effects of pulmonary embolism, post thrombotic syndrome (PTS) and chronic thromboembolic pulmonary hypertension (CTEPH) respectively. Our aim of the study is to compare the long term outcomes along with the quality of life assessment of VTE in a group treated with heparin+VKA versus a group treated with heparin+edoxaban in the acute setting.

NCT ID: NCT03937583 Recruiting - Pulmonary Embolism Clinical Trials

Screening for Cancer in Patients With Unprovoked VTE

SOME-RIETE
Start date: October 23, 2019
Phase: Phase 4
Study type: Interventional

Open and multicenter randomized clinical trial (1:1) comparing limited screening with extended screening with the performance of Positron emission tomography-computed tomography (PET-CT) scan in the search for neoplasms in patients with unprovoked venous thromboembolic disease at high risk of developing cancer at follow-up. Introduction: Cancer screening in patients with unprovoked venous thromboembolic disease (VTE) is controversial. In the last years, a score has been developed that selects patients at high risk of developing cancer during follow-up. Objective: To estimate the impact of an active cancer search strategy using 18-fluordesoxiglucose (FDG) PET-CT in unprovoked VTE with high-risk to develop cancer. Specific Objectives: 1) Number of neoplasms diagnosed in the screening process: 2) number of neoplasms diagnosed at an early stage, 3) impact on survival of the strategy; and 4) impact on the quality of life. Cancer will be considered from 30 days up to 12 months after the diagnosis of VTE. Scope: 20 Spanish hospitals. Design: Open-label, multicentre Randomized clinical trial (1: 1) comparing the performance of PET-CT versus limited screening for cancer. Population: Patients older than 18 years with unprovoked VTE at high risk of presenting cancer at follow-up (≥3 points in the score of Jara-Palomares et al., Chest 2017). Follow-up: 12 months after VTE. Sample: The sample size calculated is 650 patients, to obtain a power of 80%, with a level of significance of 5%, and taking into account a 10% loss of follow-up.

NCT ID: NCT03887806 Recruiting - Clinical trials for Venous Thromboembolic Disease

Cost Effectiveness Analysis of an Ancillary Study of the REMOTEV Study

Start date: March 20, 2019
Phase:
Study type: Observational

The implications of the medico-economic impact are essential in the choice of first-line therapists. The economic impact is an important criterion to recommend the privileged use of Direct Oral Anticoagulants (AOD) in first intention.

NCT ID: NCT03206372 Recruiting - Clinical trials for Venous Thromboembolic Disease

Risk Factors of Venous Thromboembolism in Women During Hormonal Exposure

FIT-H
Start date: October 24, 2017
Phase:
Study type: Observational

Young women have an increased risk of venous thromboembolism (VTE) during hormonale exposure (estrogen-containing pill or pregnancy). In order to detect women at higher risk of VTE during hormonal exposure, thrombophilia testing is often performed in order to adapt contraception methods and/or to increases thromboprophylaxy during pregnancy. However, such practice is probably not accurate nor discriminent. Indeed, there are evidence that the impact of the familial history of VTE might be stronger than that of detectable inherited thrombophilia. The "FIT-H" study is a cross-sectional study comparing the prevalence of previous venous thromboembolism in first-degree relatives of women (propositi) who had a first episode of venous thromboembolism in association with hormonal exposure with the prevalence of previous venous thromboembolism in first-degree relatives of women who did not have venous thromboembolism during a similar hormonal exposure. The primary objective is to determine the association between the presence or the absence of VTE in young women during hormonal exposure and the presence or the absence of a previous episode of VTE in their first-degree relatives. Secondary objective is to determine the impact of associated inherited thrombophilia on the risk of VTE in first-degree relatives.