There are 3 clinical trials
Patients with cirrhosis of viral etiology (HCV/HBV); Patients with cirrhosis of any other etiology (alcohol, idiopatic, autoimmune). Planned Number of cirrhotic subjects 200 patients Inclusion Criteria Subjects (18 yr old) with liver cirrhosis of any etiology, Exclusion Criteria All patients should not have hepatocellular carcinoma or other malignant tumors, they should not be treated with anticoagulant / antiplatelet agents, not affected by PVT already diagnosed and not suffering from congenital coagulation disorders (haemophilia A / B, von disease Willebrand, another congenital deficiency of coagulation factors) or severe thrombocytopenia (<30,000 Plt / μL). Subject has participated in another clinical study within 30 days prior to study enrollment or is scheduled to participate in another clinical study on cirrhosis Primary Objective To describe the prospective modification of ADAMTS-13 level and other coagulation variables (e.g. FVIII, VWF:Ag/VWF:act) in cirrhotic patients during 18 months from the enrolment and to verify their predictive role as biomarker of development of portal vein thrombosis (PVT) Secondary Objectives To describe prospectively the modification of ADAMTS-13 level as a function of the etiology of cirrhosis Statistical analysis The total duration of the study will be of 12 months. The sample size of 200 subjects will be selected as a feasible number of patients to be recruited in a period of six months. The patients will be consecutively enrolled and followed for 18 months. As a result, in a follow up period of 18 months about 20-25 cases of PVT are expected. Continuous variables will be expressed as means ± standard deviations. In addition to descriptive statistics (location parameters), univariate analysis will be performed on each parameter and development of PVT during the follow up period. In previous observational studies both 1) a reduced PV flow [prospectively] and 2) a reduction of ADAMTS-13 are significantly associated with PVT. These associations will be investigated prospectively and analyzed simultaneously by a multivariate analysis and ROC curve to establish the sensitivity and specificity of these parameters as predictors of PVT development. Analyses will be performed using available data
FV Leiden R506Q and prothrombin G20210A genotyping of these polymorphisms was performed by using commercial kits based on PCR-RT-based method (from EliTechGroup S.p.A., Torino, Italy) on an automatic instrument (Model 7300, Applied Biosystem, Foster City, CA, USA). --- R506Q ---
Description: Primary Endpoint To describe in a prospective way the association of both basal ADAMTS-13 level and portal vein flow with development of PVT in cirrhotic patients during 18 months from the enrolment. Measurement of ADAMTS-13 activity. ADAMTS-13 activity was measured in citrated plasma samples by a fluorescence resonance energy transfer (FRET)-based assay,Measure: Association of portal vein thrombosis with ADAMTS13 activity Time: 18 months
Description: The secondary objectives of analyzing the levels of ADAMTS-13 and VWF as a function of the etiology of cirrhosis will be further assessed only after a certified diagnosis of the particular etiologic of cirrhosis. In the case of HCV-associated cirrhosis also the genotype of HCV will be analyzed.Measure: Analysis of ADAMTS-13 and VWF levels as a function of the etiology of cirrhosis. Time: 18 months
The goal of the pilot study is to determine if a multicenter prospective cohort study of cancer patients with blood clots associated with catheters is feasible. Cancer patients with catheter-related thrombosis treated with one month of anticoagulation will be evaluated for for post-thrombotic syndrome. Laboratory biomarkers will be evaluated as predictors of recurrent thrombosis.
- >18 years of age - Platelet count >50,000 - Creatinine clearance >30 ml/min - Ability to provide informed consent Exclusion Criteria: - Underlying medical condition or chemotherapy requiring long-term anticoagulation - Known underlying higher risk thrombophilias including antiphospholipid antibody syndrome, antithrombin, protein C or protein S deficiencies, or homozygosity or compound heterozygosity for prothrombin G20210A or Factor V R506Q mutations. --- G20210A --- --- R506Q ---
Description: Recruitment of 56 patients in 1 year and 80% completion of post-thrombotic syndrome assessments by enrolled patientsMeasure: Number of cancer patients enrolled with catheter-related thrombosis treated with 1 month of anticoagulation Time: 1 year
Description: Obtaining 80% of samples from enrolled patientsMeasure: Number of plasma samples obtained for biomarker analysis to predict recurrent venous thrombosis Time: 1 year
Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removalMeasure: Incidence of post-thrombotic syndrome in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation Time: 6 months after catheter removal
Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removalMeasure: Incidence of recurrent thrombosis in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation Time: 6 months after catheter removal
Description: <20% will have incidence of post-thrombotic syndrome 6 months after catheter removalMeasure: Incidence of major and clinically relevant non-major bleeding in cancer patients with catheter-related thrombosis treated with 1 month of anticoagulation Time: 6 months after catheter removal
To determine the genetic epidemiology, including genetic and environmental interactions of the multifactorial disease, venous thromboembolism (VTE).
The high prevalence of the Factor V R506Q (Leiden) and Prothrombin 20210G --> A mutations among VTE patients suggests the hypothesis that additional genetic abnormalities of coagulation (thrombophilia) are associated with a substantial proportion of VTE cases. --- R506Q ---
Using stored DNA samples, the investigators screened for mutations within the candidate genes for Factor V R506Q (Leiden) and Prothrombin 20210G --> A using either dideoxy, bi-directional dideoxy, or restriction endonuclease fingerprinting, and performing population-based case-control and cohort studies using a previously identified 30-year VTE inception cohort. --- R506Q ---