Portal Vein Thrombosis in Cirrhosis: Incidence, Outcomes and Anticoagulation

NCT07422701 | Not Yet Recruiting DMC

• 1 other identifier: 2025R0123
• Study Type: observational
• Target: 2,522
• Locations: 1 country
• Sites: 7

Brief Summary

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. 1.Identify risk factors for new PVT and build an easy-to-use prediction model.
2. 2.Clarify the impact of PVT on prognosis, especially all-cause death and decompensation of cirrhosis.
3. 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.

Conditions

Portal Vein Thrombosis; Liver Cirrhosis

Keywords

Portal Vein Thrombosis; Liver Cirrhosis; Risk Factors; Prognosis; Anticoagulation Therapy; Bidirectional Cohort Study

Outcome Measures

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.

  24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Peking University First Hospital: lead
• 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

Study Sites (7)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Location

Shenzhen Third People's Hospital

Shenzhen, Guangdong, China

Location

Hengshui No. 3 People's Hospital

Hengshui, Hebei, China

Location

Qinhuangdao No. 3 People's Hospital

Qinhuangdao, Hebei, China

Location

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

Location

Qingdao No.6 People's Hospital

Qingdao, Shandong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood collected at baseline, 6, 12, and 24 months: 10 mL EDTA whole blood (for germline DNA extraction and buffy-coat biobanking) and 10 mL serum + 10 mL citrate plasma (for proteomic, metabolomic, and coagulation assays). Residual aliquots will be de-identified, coded, and stored at -80 °C in the central biobank of Peking University First Hospital for ≥10 years. Limited amounts of ascitic fluid (\<5 mL) may be stored when obtained for clinical reasons. No other tissues will be retained. Future use is restricted to ethically approved studies on portal vein thrombosis, liver cirrhosis, hemostasis, or related thrombotic disorders; access is governed by the Institutional Biobank Committee.

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guiqiang Wang

  Peking University First Hospital

  STUDY DIRECTOR

Central Study Contacts

Ming He

CONTACT

+86-15311273507; drheming@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2025
• First Posted: February 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: February 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)