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Oxidative Stress and Haemostasis Abnormalities in Cirrhosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by University of Roma La Sapienza.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Francesco Violi, University of Roma La Sapienza Identifier:
First received: May 23, 2012
Last updated: May 30, 2012
Last verified: May 2012

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.


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:

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

Primary Outcome Measures:
  • Oxidative stress markers [ Time Frame: 2 years ]
    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 ]
    Occurrence of thrombotic complications

  • Bleeding Events [ Time Frame: 2 years ]
    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)
Cirrhotic Patients
Patients affected by cirrhosis of any etiology and severity
Control Group
Subjects age, sex and comorbidities matched

  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients affected by cirrhosis of any etiology and severity

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01607814

Contact: Francesco Violi, MD 064461933 ext +39
Contact: Stefania Basili, MD 0649974678 ext +39

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

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

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

Additional relevant MeSH terms:
Liver Cirrhosis
Congenital Abnormalities
Pathologic Processes
Liver Diseases
Digestive System Diseases
Coagulants processed this record on April 28, 2017