Liver CirrhosisNCT02069457
Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis
An observational study of Liver Cirrhosis and Portal Vein Thrombosis, run by Jia Ji-Dong at 1 site in China.
Trial summary
Several studies have confirmed that patients with cirrhosis possess an imbalance in procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein C. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Portal Vein Thrombosis
- How many people
- 151 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhosis of any etiology and severity
Who may be able to join
- Cirrhosis of any etiology and severity, Aged 18-80 years, Signed Informed Consent.
Who cannot join
- Hepatocellular carcinoma, other intrahepatic/extrahepatic cancers, documented history of congenital coagulation disorders, pregnancy, human immunodeficiency virus (HIV) positivity, recent (<7 d) transfusion with blood products, use of anticoagulant/antiaggregation drugs in the past 10 d.
Trial locations and contacts
1 site in 1 country.
About this study
Several studies have confirmed that patients with cirrhosis possess an imbalance in procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein C. 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. The prevalence and pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The patients are going to follow up for one year and evaluate at baseline and every 6 months by liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical events will be evaluated at every follow up.
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Medical subject headings
- Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of portal vein thrombosis
To estimate the prevalence of PVT evaluated by US in a cohort of patients with liver cirrhosis of any etiology and severity.
Measured: 6 months
Secondary outcomes (3)
Cirrhosis Complications
Occurrence of digestive or other bleeding complications; Occurence of other cirrhosis-related complications ( onset or progression of oesophageal varices, ascites or refractory ascites, hepatic encephalopathy, onset of liver cancer, infections, spontaneous bacterial peritonitis, onset of hepato-renal or hepato-pulmonary syndrome)
Measured: 1 year
Incidence of portal vein thrombosis
To estimate the incidence of new onset PVT evaluated by US in a cohort of patients with cirrhosis.
Measured: 1 year
mortality
Overall mortality in a cohort of patients with cirrhosis without HCC
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jia Ji-Dong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jia Ji-Dong, Beijing Friendship Hospital
- Investigators
- Jidong Jia, Doctor, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069457
- Sponsor's protocol ID
- BJFH20140220
- Status last verified
- Jul 2015
- First submitted
- 20 Feb 2014
- Last updated
- 28 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Predictive Factors of Portal Vein Thrombosis in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT02069457
- Acronym / sponsor ID
- BJFH20140220
- Conditions
- Liver Cirrhosis, Portal Vein Thrombosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Jia Ji-DongUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Several studies have confirmed that patients with cirrhosis possess an imbalance in procoagulant versus anticoagulant activity due to increased factor VIII and decreased protein C. 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. The prevalence and pathogenesis of portal vein thrombosis (PVT) in patients with cirrhosis without hepatocellular carcinoma are not clearly defined. The Aim of this study is to assess the prevalence of portal vein thrombosis in patients with cirrhosis without hepatocellular carcinoma, and to prospectively assess the risk factors, outcome, and prognosis in these patients. The investigators plan to enroll two hundred patients with liver cirrhosis. The patients are going to follow up for one year and evaluate at baseline and every 6 months by liver function tests, coagulation test, upper abdomen ultrasound. All relevant clinical events will be evaluated at every follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis of any etiology and severity
Key inclusion criteria (1 listed)
- Cirrhosis of any etiology and severity, Aged 18-80 years, Signed Informed Consent.
Key exclusion criteria (1 listed)
- Hepatocellular carcinoma, other intrahepatic/extrahepatic cancers, documented history of congenital coagulation disorders, pregnancy, human immunodeficiency virus (HIV) positivity, recent (<7 d) transfusion with blood products, use of anticoagulant/antiaggregation drugs in the past 10 d.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of portal vein thrombosis
Time frame: 6 months
To estimate the prevalence of PVT evaluated by US in a cohort of patients with liver cirrhosis of any etiology and severity.
3 secondary outcomes
Cirrhosis Complications
Time frame: 1 year
Incidence of portal vein thrombosis
Time frame: 1 year
mortality
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jidong Jia, Doctor principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Portal Vein Thrombosis, run by Jia Ji-Dong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of portal vein thrombosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.