Portal Vein Thrombosis in Cirrhosis: Incidence, Outcomes and Anticoagulation (PORTAL)

February 13, 2026 updated by: Peking University First Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Background and rationale Portal vein thrombosis (PVT) complicates ≈10-25 % of cirrhosis cases and is linked to variceal bleeding, ascites, hepatic encephalopathy and inferior transplant-free survival. Existing data are fragmented, largely single-centre, and often exclude patients managed without anticoagulation. Consequently, clinicians still lack robust, generalisable tools for (a) predicting incident PVT, (b) quantifying its true prognostic impact, and (c) balancing the benefits and risks of real-world anticoagulant therapy.

Study design This is a seven-centre, bidirectional cohort comprising a retrospective arm (chart review of 1 682 cirrhotic adults hospitalised) and a prospective arm that will enrol ≈ 840 additional patients, yielding a total target size of ≈ 2 500 subjects. Eligible participants are aged ≥18 years, have imaging-confirmed cirrhosis (any aetiology), and can be stratified into three baseline states: (1) no PVT, (2) focal or partial PVT, or (3) occlusive/complete PVT. Key exclusions are hepatocellular carcinoma invading the portal vein, Budd-Chiari syndrome, current pregnancy, or life expectancy < 3 months.

Data collection and follow-up At index admission (or first study visit) the team records demographics, liver disease aetiology, Child-Pugh/MELD scores, thrombophilia panel, abdominal Doppler/CT, and treatment decisions (including anticoagulant class, dose and duration). Follow-up contacts are scheduled at 6 ± 1 months, 12 ± 2 months and 24 ± 3 months via clinic visit, electronic health record extraction or structured telephone interview . End-points captured at each contact include incident PVT, progression/regression of an existing thrombosis, major bleeding (ISTH criteria), liver-related decompensation, transplantation and all-cause mortality.

Statistical plan Predictors of incident PVT will be screened with univariable Fine-Gray competing-risk models (death/transplant as competing events); independent factors will enter a multivariable model to derive a PVT-Risk Score. Model performance will be quantified by Harrell's C-index, time-dependent AUROC and calibration plots, with bootstrap internal validation and external temporal validation using the prospective sub-cohort. Propensity-score overlap weighting will compare anticoagulation versus no-anticoagulation for key outcomes, while multi-state Markov models will characterise transitions between "no PVT", "partial PVT", "complete PVT" and "death/transplant". Pre-specified subgroup analyses include Child-Pugh class, non-selective β-blocker use and thrombophilia status.

Study Type

Observational

Enrollment (Estimated)

2522

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100034
      • Beijing, Beijing Municipality, China
        • Beijing Youan Hospital, Capital Medical University
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China
        • Shenzhen Third People's Hospital
        • Contact:
    • Hebei
      • Hengshui, Hebei, China
        • Hengshui No. 3 People's Hospital
        • Contact:
      • Qinhuangdao, Hebei, China
        • Qinhuangdao No. 3 People's Hospital
        • Contact:
    • Jiangsu
      • Wuxi, Jiangsu, China
        • Wuxi No.5 People's Hospital
        • Contact:
    • Shandong
      • Qingdao, Shandong, China
        • Qingdao No.6 People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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
  • Complete baseline clinical, laboratory, and imaging data available
  • Able and willing to provide written informed consent and comply with 24-month follow-up

Exclusion Criteria:

  • 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
  • Known hereditary thrombophilia or active systemic inflammatory disease
  • Inability or unwillingness to participate in scheduled follow-up (e.g., cognitive impairment, residence far from study sites)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PVT Group
Patients with liver cirrhosis diagnosed with portal vein thrombosis (PVT) by imaging at baseline.
Non-PVT Group
Patients with liver cirrhosis without portal vein thrombosis (PVT) confirmed by imaging at baseline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-Cause Mortality
Time Frame: 24 months
The cumulative incidence proportion of death from any cause. Death will be ascertained through hospital electronic records, death certificates, or structured telephone follow-up.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Beijing YouAn Hospital
Shenzhen Third People's Hospital
Wuxi No.5 People's Hospital
Qingdao No.6 People's Hospital
Hengshui No. 3 People's Hospital
Qinhuangdao No. 3 People's Hospital

Investigators

  • Study Director: Guiqiang Wang, Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 13, 2025

First Submitted That Met QC Criteria

February 13, 2026

First Posted (Actual)

February 20, 2026

Study Record Updates

Last Update Posted (Actual)

February 20, 2026

Last Update Submitted That Met QC Criteria

February 13, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025R0123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Current ethics approval and national regulations do not permit external sharing of individual-level data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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