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Thromboses, Venous clinical trials

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NCT ID: NCT05679024 Recruiting - Stroke Clinical Trials

Stroke Prophylaxis With Apixaban in Chronic Kidney Disease Stage 5 Patients With Atrial Fibrillation

SACK
Start date: February 17, 2023
Phase: Phase 3
Study type: Interventional

Objective: To study the efficacy and safety of apixaban as stroke prophylaxis in patients with chronic kidney disease (CKD) stage 5 and atrial fibrillation (AF) with or without dialysis treatment. The study hypothesis is that compared to no anticoagulation, apixaban reduces the incidence of ischemic stroke without causing an unacceptable increase in fatal or intracranial bleeding events. The secondary objectives are to evaluate the risk of all-cause mortality, cardiovascular events, and major bleeding in people with CKD stage 5 and AF treated with apixaban compared to standard of care without anticoagulation. Trial design: Pragmatic Prospective Open Label Randomized Controlled Clinical Trial, phase 3b over 12-72 months. Trial population: 1000-1400 patients at ≈50 sites in Sweden, Finland, Norway, Iceland and Poland Eligibility criteria: Adults ≥18 years with CKD stage 5 (ongoing treatment with any chronic dialysis treatment OR an estimated glomerular filtration rate (eGFR)* <20 ml/min/1.73 m2 at least twice 3 months apart of which at least one occasion is <15 ml/min/1.73 m2 due to CKD during the last 12 months) and a diagnosis of chronic, paroxysmal, persistent, or permanent AF or atrial flutter (AFL) with CHA2DS2-VASc score ≥2 for men or ≥3 or more for women as an indication for oral anticoagulation. The exclusion criteria are AF or AFL due to reversible causes, rheumatic mitral stenosis or moderate-to-severe non-rheumatic mitral stenosis at the time of inclusion into the study, a condition other than AF or AFL that requires chronic anticoagulation, contraindications for anticoagulation, active bleeding or serious bleeding within 3 months, planned for surgery within 3 months, and current use of strong inhibitors of both CYP3A4 and P-glycoprotein. Interventions: Randomization 1:1 to treatment with apixaban 2.5 mg twice daily and standard of care, or standard of care and no anticoagulation. Outcome measures: primary efficacy (time to first ischemic stroke); primary safety (the composite of time to first intracranial bleeding or fatal bleeding); secondary efficacy (time to all-cause mortality, time to cardiovascular event or cardiovascular death); secondary safety (time to first major bleeding according to International Society on Thrombosis and Hemostasis (ISTH) criteria)

NCT ID: NCT04608591 Recruiting - Lower Limb Injury Clinical Trials

A Prospective Study to Assess the Risk Factors That Contribute to Thrombosis in Patients With Lower Limb Injuries.

TILLIRI
Start date: December 1, 2018
Phase:
Study type: Observational

- This study is aimed at identifying patients at high risk for Venous Thrombo-Embolism (VTE) (clots in the veins of legs or clots in the lungs) who have lower limb injuries treated with immobilisation of the lower limb. The study aims to identify high risk patients, who may benefit from thromboprophylaxis (blood thinning medication) to prevent such clots forming. - To do this we will collect data on 3500 patients who present with lower limb injury requiring immobilisation to the Emergency Departments of the six hospitals named. - We will assess their risk factors for venous thrombosis at the time of presentation and contact them at twelve weeks to assess if they have had a VTE in order to develop a risk scoring system which can be used to predict the likelihood of VTE development - This risk scoring system can then be used to identify high risk patients who may benefit from thromboprophylaxis.

NCT ID: NCT04546750 Recruiting - Clinical trials for Venous Insufficiency

Prospective Cohort Study for Varicose Veins Incidence and Natural Course

VINCI
Start date: September 1, 2020
Phase:
Study type: Observational

A prospective study of individuals without varicose veins and who have primary varicose veins to assess the morbidity, risk factors and natural course of chronic lower limb vein disease.

NCT ID: NCT04354155 Completed - COVID-19 Clinical Trials

COVID-19 Anticoagulation in Children - Thromboprophlaxis (COVAC-TP) Trial

Start date: June 2, 2020
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, dose-requirements, and exploratory efficacy of twice-daily subcutaneous enoxaparin as venous thromboembolism prophylaxis in children (birth to 18 years) hospitalized with signs and/or symptoms of SARS-CoV-2 infection (i.e., COVID-19).

NCT ID: NCT03908866 Recruiting - Infection Clinical Trials

Peripherally Inserted Versus Centrally Inserted Central Venous Catheters in the Neurosurgical Intensive Care Unit

PICINI
Start date: April 1, 2019
Phase: N/A
Study type: Interventional

This study aim to compare the cost-effectiveness and safety between centrally and peripherally inserted central venous catheters in neurosurgical intensive care unit patients.

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: NCT03784937 Completed - Clinical trials for Deep Vein Thrombosis

Revaluation of Wells' Clinical Prediction Score of Deep Vein Thrombosis (DVT) in Inpatients With Thromboprophylaxis Treatment

R-WITT
Start date: February 1, 2018
Phase:
Study type: Observational

This study aimed (1) revaluating the efficacy of the Wells' clinical prediction score for an inpatient population; and the weight of the presence of thromboprophylaxis treatment on the score, and (2) evaluating the correlation of a risk stratification established between a physician specialised in thrombosis and any other doctor.