Portal Vein ThrombosisPORTALNCT07422701
Portal Vein Thrombosis in Cirrhosis: Incidence, Outcomes and Anticoagulation
An observational study of Portal Vein Thrombosis and Liver Cirrhosis, run by Peking University First Hospital at 7 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Portal Vein Thrombosis, Liver Cirrhosis
- How many people
- 2,522 participants
- Where
- 7 sitesChina
- Study dates
- 1 Feb 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ming He, drheming@163.com
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality
Huiguo Ding, +86-13911683832, dinghuiguo@ccmu.edn.cn
Hengshui No. 3 People's Hospital
Hengshui, Hebei
Suoxiang Zhang, +86-13831847646, zsx2129995@163.com
Qingdao No.6 People's Hospital
Qingdao, Shandong
Wei Gou, +86-15666687727, gouwei_qd@126.com
Qinhuangdao No. 3 People's Hospital
Qinhuangdao, Hebei
Liang Miao, +86-15232376941, miaoliang202202@126.com
Shenzhen Third People's Hospital
Shenzhen, Guangdong
Qingxian Cai, +86-18127814825, cqx200000@163.com
Wuxi No.5 People's Hospital
Wuxi, Jiangsu
Yuanwang Qiu, +86-13861872462, qywang839@126.com
About this study
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 :
Read more
- Identify risk factors for new PVT and build an easy-to-use prediction model.
- Clarify the impact of PVT on prognosis, especially all-cause death and decompensation of cirrhosis.
- 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.
Read the 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.
- Conditions
- Portal Vein Thrombosis, Liver Cirrhosis
- Keywords
- Portal Vein Thrombosis, Liver Cirrhosis, Risk Factors, Prognosis, Anticoagulation Therapy, Bidirectional Cohort Study
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Portal Vein ThrombosisStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 2,522 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Third People's Hospital, Beijing YouAn 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
- Responsible party
- Sponsor
- Investigators
- Guiqiang Wang, Study director, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07422701
- Sponsor's protocol ID
- 2025R0123
- Acronym
- PORTAL
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2025
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Current ethics approval and national regulations do not permit external sharing of individual-level data.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Thrombosis in Cirrhosis: Incidence, Outcomes and Anticoagulation
- ClinicalTrials.gov ID
- NCT07422701
- Acronym / sponsor ID
- PORTAL / 2025R0123
- Conditions
- Portal Vein Thrombosis, Liver Cirrhosis
- Keywords
- Portal Vein Thrombosis, Liver Cirrhosis, Risk Factors, Prognosis, Anticoagulation Therapy, Bidirectional Cohort Study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,522 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Third People's Hospital, Beijing YouAn 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
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- 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.
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 :
- Identify risk factors for new PVT and build an easy-to-use prediction model.
- Clarify the impact of PVT on prognosis, especially all-cause death and decompensation of cirrhosis.
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Individual participant dataSharing planned: No. Current ethics approval and national regulations do not permit external sharing of individual-level data.
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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.
Guiqiang Wang study director
Peking University First Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Portal Vein Thrombosis and Liver Cirrhosis, run by Peking University First Hospital at 7 sites 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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming He (+86-15311273507, drheming@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-Cause Mortality (time frame: 24 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 20 Feb 2026.