Oxidative Stress and Haemostasis Abnormalities in Cirrhosis
Recruitment status was Recruiting
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 Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Oxidative Stress and Haemostasis Abnormalities in Cirrhosis|
- 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.
- 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
|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)|
Patients affected by cirrhosis of any etiology and severity
Subjects age, sex and comorbidities matched
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01607814
|Contact: Francesco Violi, MD||064461933 ext +firstname.lastname@example.org|
|Contact: Stefania Basili, MD||0649974678 ext +email@example.com|
|Internal and Medical Specialties Department, Policlinico Umberto I||Recruiting|
|Rome, Italy, 00161|
|Contact: Francesco Violi, MD 064461933 ext +39 firstname.lastname@example.org|
|Contact: Stefania Basili, MD 0649974678 ext +39 email@example.com|
|Principal Investigator: Francesco Violi, MD|
|Sub-Investigator: Stefania Basili, MD|
|Study Chair:||Francesco Violi, MD||Divisione di Prima Clinica Medica - Sapienza University of Rome|