Status:
UNKNOWN
ADAMTS-13 LEVEL AS PREDICTIVE BIOMARKER FOR DEVELOPMENT OF PORTAL VEIN THROMBOSIS IN LIVER CIRRHOSIS (ADAPTHRO)
Lead Sponsor:
Raimondo De Cristofaro
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18+ years
Brief Summary
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 Criteri...
Detailed Description
BACKGROUND AND JUSTIFICATION The occurrence of portal vein thrombosis (PVT) radically changes the prognosis of cirrhotic patients, particularly those awaiting liver transplantation. If this happens, i...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- Patients with liver cirrhosis of any etiology, diagnosed using imaging and/or histological criteria and observed in the Liver Unit of the "A. Gemelli" University will be included in this study. All patients will sign an informed consent. The severity of liver function failure will be assessed using the Child-Pugh score \[11\]. Upper gastrointestinal endoscopy will be performed in all patients; the size of esophageal varices will be recorded as well as the presence of previous episodes of gastrointestinal bleeding. All the subjects will be outpatients and the time interval between the follow up visits will be approximately 120 days. The ultrasound criteria for the diagnosis of PVT will be the detection of echogenic material within one or more of the following vessels: portal trunk, right portal branch, left portal branch, splenic vein and superior mesenteric vein. Color and pulsed Doppler analysis will allow to confirm the diagnosis and to distinguish partial from complete obstructive thrombosis and in all cases the Doppler ultrasound diagnosis of PVT will be confirmed by contrast enhanced abdomen computed tomography. The presence and/or extension of the thrombosis to the other major vessels of the portal venous system (mesenteric or splenic vein) will registered in all patients. PVT will be classified according to the extension of thrombosis, as previously reported: grade I is referred to as portal thrombosis confined to the portal vein beyond the confluence of the splenic vein; grade II was a PVT extended to the superior mesenteric vein, but with patent mesenteric vessels; grade III is a PVT extended to the whole splanchnic venous system, but with large collaterals; grade IV is a thrombosis extended to the whole splanchnic venous system with only fine collaterals \[12\]. All the biochemical and coagulation parameters described below, including ADAMTS-13 and VWF levels, will be measured at each follow up visit.
Exclusion
- 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/µl).
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03322696
Start Date
October 1 2017
End Date
June 30 2021
Last Update
November 12 2020
Active Locations (1)
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1
Raimondo De Cristofaro
Roma, Italy, 00168