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Oxidative Stress and Haemostasis Abnormalities in Cirrhosis

This study is currently recruiting participants.
Verified May 2012 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01607814
First received: May 23, 2012
Last updated: May 30, 2012
Last verified: May 2012
History of Changes
  Purpose

Patients with cirrhosis can have abnormalities in laboratory tests reflecting changes in primary and secondary haemostasis.

Such changes have been considered particularly relevant in the bleeding complications that occur in cirrhosis.

However, several studies have shown that routine diagnostic tests are not clinically useful to stratify bleeding risk in patients with cirrhosis. Moreover, treatments used to increase platelet count or to modulate platelet function could potentially do harm. Consequently the optimal management of bleeding complications is still a matter of discussion.

Moreover, in the last two decades there has been an increased recognition that not only bleeding but also thrombosis complicates the clinical course of cirrhosis. Over the last years, emerge that in vivo platelet function and coagulation cascade might be modulated by an alteration of pro-oxidant and antioxidant balance. Thus It has previously been demonstrated that chronic liver diseases are characterized by increased oxidative stress state.

Aim of the study is to analyse the relationship between oxidative stress, haemostatic balance and clinical complications in cirrhosis.


Condition
Cirrhosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Oxidative Stress and Haemostasis Abnormalities in Cirrhosis

Resource links provided by NLM:

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Oxidative stress markers [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Evaluate the F2-Isoprostanes, in vivo oxidative stress markers, production in cirrhotic patients and its influence on haemostatic balance.


Secondary Outcome Measures:
  • Thrombotic Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Occurrence of thrombotic complications

  • Bleeding Events [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Occurrence of bleeding complications


Biospecimen Retention:   Samples Without DNA

Plasma, serum and urine samples


Estimated Enrollment: 200
Study Start Date: November 2011
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cirrhotic Patients
Patients affected by cirrhosis of any etiology and severity
Control Group
Subjects age, sex and comorbidities matched

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients affected by cirrhosis of any etiology and severity

Criteria

Inclusion Criteria:

  • Cirrhosis of any etiology and severity
  • Signed Written Informed Consent

Exclusion Criteria:

  • Treatment with non steroidal anti-inflammatory drugs or antithrombotic drugs (antiplatelets and anticoagulants)
  • Vitamin Supplementation
  • Pregnancy
  • Cholestatic liver disease
  • Hepatocarcinoma and Extrahepatic neoplasm
  • Active infective or inflammatory diseases
  • Recent major or minor surgery (< 3 months)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607814

Contacts
Contact: Francesco Violi, MD 064461933 ext +39 francesco.violi@uniroma1.it
Contact: Stefania Basili, MD 0649974678 ext +39 stefania.basili@uniroma1.it

Locations
Italy
Internal and Medical Specialties Department, Policlinico Umberto I Recruiting
Rome, Italy, 00161
Contact: Francesco Violi, MD     064461933 ext +39     francesco.violi@uniroma1.it    
Contact: Stefania Basili, MD     0649974678 ext +39     stefania.basili@uniroma1.it    
Principal Investigator: Francesco Violi, MD            
Sub-Investigator: Stefania Basili, MD            
Sponsors and Collaborators
University of Roma La Sapienza
Investigators
Study Chair: Francesco Violi, MD Divisione di Prima Clinica Medica - Sapienza University of Rome
  More Information

No publications provided

Responsible Party: Francesco Violi, Director, Head of Internal Medicine, Principal Investigator, Clinical Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01607814     History of Changes
Other Study ID Numbers: Cirrhosis and Oxidative Stress
Study First Received: May 23, 2012
Last Updated: May 30, 2012
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
cirrhosis
oxidative stress
NADPH oxidase
isoprostanes
 PUFA balance
platelet activation
coagulation abnormalities

Additional relevant MeSH terms:
Congenital Abnormalities
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes
 Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013