Portal Vein Thrombosis in Cirrhosis: Incidence, Outcomes and Anticoagulation

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorPeking University First Hospital

About this trial

Portal vein thrombosis (PVT) is a blood-clot complication that occurs in some people with liver cirrhosis and can worsen bleeding, ascites, encephalopathy and survival. However, doctors still lack reliable tools to predict who will develop PVT, how much it really shortens life, and whether anticoagulation (blood-thinner) treatment clearly improves outcomes and is safe.This multicentre, bidirectional cohort study will follow about 2,500 adults with cirrhosis cared for at seven major hospitals in China. The team will first review 1,682 historical cases recorded since 2010 and then prospectively enrol another 840 patients from June 2025 onward. Participants may or may not already have PVT when they enter the study. All will undergo routine blood tests and abdominal imaging, and will be followed at roughly 6 months, 1 year and 2 years after discharge, through clinic visits, hospital records or telephone calls.

The study has three goals :

1. Identify risk factors for new PVT and build an easy-to-use prediction model. 2. Clarify the impact of PVT on prognosis, especially all-cause death and decompensation of cirrhosis. 3. Evaluate real-world anticoagulation: patients who receive blood-thinners will be compared with those who do not, looking at survival, clot progression or resolution, and major bleeding events.

Because no experimental drug or random assignment is involved, participation does not change a patient's routine care. All personal information will be de-identified and protected according to Chinese data-security laws. Results from this study are expected to help doctors recognise high-risk patients earlier and choose safer, more effective anticoagulation strategies to improve quality of life and survival in cirrhosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Clinically or histologically confirmed liver cirrhosis (any etiology)

Contrast-enhanced abdominal ultrasound, CT, or MRI performed within 3 months before enrollment to document presence or absence of portal vein thrombosis (PVT)

Complete baseline clinical, laboratory, and imaging data available

Disqualifiers

Concomitant malignant tumor, including hepatocellular carcinoma

Previous transjugular intrahepatic portosystemic shunt (TIPS), splenectomy, or liver transplantation

Major surgery or severe trauma within 6 months prior to enrollment

Pregnancy or breastfeeding

Trial population

Consecutive adult patients with compensated or decompensated liver cirrhosis who are admitted to, or followed at, seven tertiary hospitals in China (Peking University First Hospital plus six regional centers). Both patients with imaging-confirmed portal vein thrombosis and those without PVT at baseline are eligible. The anticipated enrollment is 2 522 participants of either sex and all cirrhosis etiologies.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

2,522 Participants
are grouped into 2 trial groups
Group A: PVT Group
Group B: Non-PVT Group

Trial outcomes

Primary outcomes

1

All-Cause Mortality

The cumulative incidence proportion of death from any cause. Death will be ascertained through hospital electronic records, death certificates, or structured telephone follow-up.

Time frame
24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University First Hospital

Lead sponsor

Shenzhen Third People's Hospital

Collaborator

Beijing YouAn Hospital

Collaborator

Wuxi No.5 People's Hospital

Collaborator

Qingdao No.6 People's Hospital

Collaborator

Hengshui No. 3 People's Hospital

Collaborator

Qinhuangdao No. 3 People's Hospital

Collaborator

This trial is not recruiting at the moment. You can still explore other options: