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Thromboembolism clinical trials

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NCT ID: NCT04304651 Recruiting - Clinical trials for Embolism and Thrombosis

Screening for Occult Malignancy in Patients With Unprovoked Venous Thromboembolism

MVTEP2/SOME2
Start date: September 8, 2020
Phase: N/A
Study type: Interventional

Venous thromboembolism (VTE) can be the earliest sign of cancer. Identifying occult cancers at the time of VTE diagnosis may lead to significant improvement of patients' care. This is also an upmost issue for patients who want to know if an underlying cancer might have triggered the VTE. An individual patient-level data meta-analysis (IPDMA) supports extensive screening strategies for occult cancer especially based on FDG PET/CT, and suggests that the best target population for cancer screening would be patients with unprovoked VTE older than 50 years of age (6.7% in patients aged 50 years or more vs. 1.0% in patients of less than 50 years (OR: 7.1, 95% CI: 3.1 to 16%).

NCT ID: NCT04301362 Recruiting - Cancer Clinical Trials

Biomarkers of Thrombosis as Predictors of Venous Thromboembolism Risk in Cancer Patients

FIIT_Score
Start date: July 19, 2019
Phase:
Study type: Observational

The main venous thromboembolism (VTE) risk prediction model for ambulatory cancer patients is Khorana. Cancer thrombosis is associated with elevated thrombin generation. Its quantification is a promising method for evaluating patient's thrombotic profile. This study aims to develop a predictive model of VTE risk in ambulatory cancer patients, combining thrombosis biomarkers (D-dimers and thrombin generation potential) with the Khorana score. This is a prospective observational study that includes newly diagnosed cancer patients proposed for anti-tumor treatment (chemotherapy, immunotherapy or targeted therapies). Patients with disease progression are allowed if chemotherapy-free for 3 months. A 6-month mean incidence of VTE 6-10% is expected, requiring a sample size of 600 patients. Blood sample is collected at inclusion to analyze thrombosis biomarkers and blood count. The primary endpoint is the occurrence of symptomatic or incidental VTE within 6 months of inclusion. Models will follow a logistic approach with K-fold cross-validation (k=10). Model quality will be assessed with Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC). Decision for entering predictors in multivariate models will be based on p <.10 in the univariate analysis.

NCT ID: NCT04295486 Recruiting - Clinical trials for Venous Thromboembolism

Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty

Start date: March 1, 2021
Phase: Phase 2
Study type: Interventional

This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.

NCT ID: NCT04294589 Recruiting - Colorectal Cancer Clinical Trials

Evaluation of NETs in Patients With Solid Cancers Associated With a High Risk of Venous Thromboembolic Events

Flownet
Start date: July 1, 2019
Phase:
Study type: Observational

Venous Thromboembolic Events (ETVs) are the second leading cause of death (9.2% of causes of death) in cancer patients after tumor progression (1). Indeed, cancer is associated with a 4 to 7-fold risk of ETV during chemotherapy (2). This complication is observed in 20% of cancer patients (3), and is sometimes an inaugural manifestation of cancer. This risk is particularly increased during the first 3 months after cancer diagnosis (4). A biomarker correlated with the occurrence of ETVs would make it possible to target patients at high risk of thrombosis who could benefit from primary thromboprophylaxis, thus avoiding the complications, particularly haemorrhagic, and the additional costs associated with the long-term diagnostic and therapeutic management of ETVs. The investigator has implemented in the laboratory an innovative approach to the detection and quantification of circulating NETs by flow cytometry (FCM) allowing the routine determination of NETs. Therefore the investigator propose to assess NETs by CMF in a cohort of cancer patients with a very high risk of ETVs (pancreatic cancer, gastric cancer and colon cancer).

NCT ID: NCT04263038 Recruiting - Clinical trials for Cardiovascular Diseases

Clinical Surveillance vs. Anticoagulation for Low-risk Patients With Isolated Subsegmental Pulmonary Embolism

SAFE-SSPE
Start date: May 15, 2020
Phase: Phase 4
Study type: Interventional

The clinical significance of pulmonary embolism (PE) limited to the subsegmental pulmonary arteries, so called isolated subsegmental pulmonary embolism (SSPE), remains controversial. Whether isolated SSPE represents "true" PE, a clinically more benign form of PE, a physiologic lung clearing process, or a false positive result (artifact) is currently unclear and hence, whether patients with isolated SSPE benefit from anticoagulant treatment is uncertain. Despite growing evidence from observational studies that withholding anticoagulation may be a safe option in selected patients with isolated SSPE (i.e., those without concomitant deep vein thrombosis, cancer, etc.), most patients with isolated SSPE receive anticoagulant treatment, which is associated with an increased risk of bleeding. The overall objective of the randomized controlled SAFE-SSPE trial is to evaluate the efficacy and safety of clinical surveillance without anticoagulation compared to anticoagulation treatment in low-risk patients with isolated SSPE.

NCT ID: NCT04258488 Recruiting - Thromboembolism Clinical Trials

Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

RENOVATE
Start date: February 21, 2022
Phase: Phase 4
Study type: Interventional

This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.

NCT ID: NCT04257487 Recruiting - Clinical trials for Venous Thromboembolism

Sulodexide, VESSEL®, for the Prevention of Recurrent Venous Thromboembolism (The Jason Study)

Jason
Start date: December 21, 2020
Phase: Phase 3
Study type: Interventional

The study aims at optimizing extended management of elderly patients (> 75 years) with at least one of the known bleeding risk factor, who suffered from first episode of venous thromboembolism of the lower extremity (proximal deep vein thrombosis with or without pulmonary embolism) (VTE). Patients were randomized to receive three different treatment: Sulodexide 250 mg BIS in die; Sulodexide 500 BID in die or indistinguishable placebo to verify the efficacy and safety of extended treatment for 12 months with Sulodexide (Vessel®) in the secondary prevention of Deep Vein Thrombosis / Pulmonary Embolism (DVT/PE) recurrence.

NCT ID: NCT04246073 Recruiting - Cancer Clinical Trials

Prospective Evaluation of Efficacy and Safety of Fondaparinux in Surgical Cancer Patients, Risk Factors for Thromboembolism

Start date: February 1, 2019
Phase:
Study type: Observational [Patient Registry]

Non interventional multi-centric study that will aim in evaluating the efficacy and safety of Fondaparinux in surgical cancer patients, identifying in parallel the most relevant and critical risk factors for Thromboembolism.

NCT ID: NCT04237974 Recruiting - Pulmonary Embolism Clinical Trials

Prognostic Tools in Patients With Acute Pulmonary Thromboembolism.

Start date: April 20, 2021
Phase:
Study type: Observational

Acute pulmonary embolism (PE) is a serious disease associated with high mortality rates despite advanced therapeutic options. The treatment options depend on the severity of the disease and the short - term mortality varies widely from 2 to 95%, depending on the severity of the condition

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.