Oxidative Stress and Haemostasis Abnormalities in Cirrhosis

NCT01607814 | Unknown DMC

• 1 other identifier: Cirrhosis and Oxidative Stress
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis

Keywords

cirrhosis; oxidative stress; NADPH oxidase; isoprostanes; PUFA balance; platelet activation; coagulation abnormalities

Outcome Measures

Primary Outcomes (1)

• Oxidative stress markers

  Evaluate the F2-Isoprostanes, in vivo oxidative stress markers, production in cirrhotic patients and its influence on haemostatic balance.

  2 years

Secondary Outcomes (2)

• Thrombotic Events

  2 years

• Bleeding Events

  2 years

Study Arms (2)

Cirrhotic Patients

Patients affected by cirrhosis of any etiology and severity

Control Group

Subjects age, sex and comorbidities matched

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients affected by cirrhosis of any etiology and severity

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Internal and Medical Specialties Department, Policlinico Umberto I

Rome, Rome, 00161, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum and urine samples

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Francesco Violi, MD

  Divisione di Prima Clinica Medica - Sapienza University of Rome

  STUDY CHAIR

Central Study Contacts

Francesco Violi, MD

CONTACT

064461933; francesco.violi@uniroma1.it

Stefania Basili, MD

CONTACT

0649974678; stefania.basili@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Internal Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 23, 2012
• First Posted: May 30, 2012
• Study Start: November 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

IT (1)