Thrombocytopenia Related to Chronic Liver DiseaseAC in PVTNCT07885969
Safety of Anticoagulation Therapy in Cirrhotic Patients With PVT and Severe Thrombocytopenia
An observational study of Thrombocytopenia Related to Chronic Liver Disease and Anticoagulation Treatment, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
Severe thrombocytopenia (platelet count ≤ 50 × 10^9/L) can significantly increase the risk of bleeding. Safety of Anticoagulation (AC) therapy in cirrhotic patients with portal vein thrombosis (PVT) and severe thrombocytopenia is unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment, Safety
- What is being tested?
- Anticoagulation Therapy
- Type of treatment
- Injection or infusion
- How many people
- 304 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2025
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: cirrhotic patients with PVT were assigned to either the AC group or the control group in accordance with receiving AC therapy or not
Who may be able to join
- Ranged from 18 to 75 years old in age
- Cirrhosis was diagnosed by clinical, laboratory, and radiological studies or liver biopsies
- PVT was distinguished based on abdominal contrastenhanced computed tomography (CT) or contrastenhanced magnetic resonance angiography (MRI) before endoscopy
- Platelets no less than 30×109/L
- Completion of at least 6 months of follow-up
Who cannot join
- Patients with hepatocellular tumor or other extrahepatic malignancy
- Unmanageable active bleeding
- History of TIPS treatment
- Creatinine more than 170 µmol/L
- The cavernous angiomas formation of the portal vein
- Pregnancy or lactation period
- Budd-Chiari syndrome were excluded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety of Anticoagulation Therapy in Cirrhotic Patients With Portal Vein Thrombosis and Severe Thrombocytopenia as Long as Platelet Counts no Less Than 30×10^9/L
Severe thrombocytopenia (platelet count ≤ 50 × 10^9/L) can significantly increase the risk of bleeding. Safety of Anticoagulation (AC) therapy in cirrhotic patients with portal vein thrombosis (PVT) and severe thrombocytopenia is unknown. Our study aimed to determine safety of AC therapy in cirrhotic PVT patients having platelet counts no less than 30×10^9/L, especially in those with platelet counts between 30-50×10^9/L.
Read the detailed description
This is a retrospective cohort study including cirrhotic patients with PVT at Qilu Hospital of Shandong University, Liaocheng People's Hospital and Taian City Central Hospital between January 2022 to May 2025. The study protocol was approved by the Institutional Ethics Committee of Qilu Hospital of Shandong University. Main eligible criteria: (1) ranged from 18 to 75 years old in age; (2) cirrhosis was diagnosed by clinical, laboratory, and radiological studies or liver biopsies; (3) PVT was distinguished based on abdominal contrastenhanced computed tomography (CT) or contrastenhanced magnetic resonance angiography (MRI) before endoscopy; (4) platelets no less than 30×109/L; (5) completion of at least 6 months of follow-up. Patients with hepatocellular tumor or other extrahepatic malignancy; unmanageable active bleeding; history of TIPS treatment; creatinine more than 170 µmol/L; the cavernous angiomas formation of the portal vein; pregnancy or lactation period; Budd-Chiari syndrome were excluded. Patients were assigned to either the AC group or the control group in accordance with receiving AC therapy or not.
- Conditions
- Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment, Safety, Portal Vein Thrombosis
- Being tested
- Anticoagulation Therapy
- Keywords
- Thrombocytopenia, Anticoagulation, Liver cirrhosis, Portal vein thrombosis, Safety
- Medical subject headings
- Thrombocytopenia, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anticoagulation TherapyDrug
The AC group were injected nadroparin calcium subcutaneously every 12 hours. Those who have serious varies or variceal bleeding can started AC therapy after endoscopic therapy. AC drugs was discontinued 3 days before endoscopic treatment. The control group did not administered any AC drugs.
| Study group | Role | What they receive |
|---|---|---|
| anticoagulation group | cirrhotic patients with PVT receiving anticoagulation therapy Receives: Drug: Anticoagulation Therapy | |
| the control group | cirrhotic patients with PVT not receiving AC therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of major bleeding
1-month,3-month,6-month major bleeding
Measured: 6-month
mortality
1-month,3-month,6-month all-cause mortality
Measured: 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Sep 2025
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytopenia Related to Chronic Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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
- Retrospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Liaocheng People's Hospital, Taian City Central Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07885969
- Sponsor's protocol ID
- 20261013-Qilu
- Acronym
- AC in PVT
- Status last verified
- Oct 2026
- First submitted
- 14 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Anticoagulation Therapy in Cirrhotic Patients With Portal Vein Thrombosis and Severe Thrombocytopenia as Long as Platelet Counts no Less Than 30×10^9/L
- ClinicalTrials.gov ID
- NCT07885969
- Acronym / sponsor ID
- AC in PVT / 20261013-Qilu
- Conditions
- Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment, Safety, Portal Vein Thrombosis
- Keywords
- Thrombocytopenia, Anticoagulation, Liver cirrhosis, Portal vein thrombosis, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Liaocheng People's Hospital, Taian City Central Hospital
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 21 Oct 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.
Severe thrombocytopenia (platelet count ≤ 50 × 10^9/L) can significantly increase the risk of bleeding. Safety of Anticoagulation (AC) therapy in cirrhotic patients with portal vein thrombosis (PVT) and severe thrombocytopenia is unknown. Our study aimed to determine safety of AC therapy in cirrhotic PVT patients having platelet counts no less than 30×10^9/L, especially in those with platelet counts between 30-50×10^9/L.
Detailed description
This is a retrospective cohort study including cirrhotic patients with PVT at Qilu Hospital of Shandong University, Liaocheng People's Hospital and Taian City Central Hospital between January 2022 to May 2025. The study protocol was approved by the Institutional Ethics Committee of Qilu Hospital of Shandong University. Main eligible criteria: (1) ranged from 18 to 75 years old in age; (2) cirrhosis was diagnosed by clinical, laboratory, and radiological studies or liver biopsies; (3) PVT was distinguished based on abdominal contrastenhanced computed tomography (CT) or contrastenhanced magnetic resonance angiography (MRI) before endoscopy; (4) platelets no less than 30×109/L; (5) completion of at least 6 months of follow-up. Patients with hepatocellular tumor or other extrahepatic malignancy; unmanageable active bleeding; history of TIPS treatment; creatinine more than 170 µmol/L; the cavernous angiomas formation of the portal vein; pregnancy or lactation period; Budd-Chiari syndrome were excluded. Patients were assigned to either the AC group or the control group in accordance with receiving AC therapy or not.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anticoagulation group | – | Drug: Anticoagulation Therapycirrhotic patients with PVT receiving anticoagulation therapy |
| the control group | – | –cirrhotic patients with PVT not receiving AC therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- cirrhotic patients with PVT were assigned to either the AC group or the control group in accordance with receiving AC therapy or not
Key inclusion criteria (5 listed)
- Ranged from 18 to 75 years old in age
- Cirrhosis was diagnosed by clinical, laboratory, and radiological studies or liver biopsies
- PVT was distinguished based on abdominal contrastenhanced computed tomography (CT) or contrastenhanced magnetic resonance angiography (MRI) before endoscopy
- Platelets no less than 30×109/L
- Completion of at least 6 months of follow-up
Key exclusion criteria (7 listed)
- Patients with hepatocellular tumor or other extrahepatic malignancy
- Unmanageable active bleeding
- History of TIPS treatment
- Creatinine more than 170 µmol/L
- The cavernous angiomas formation of the portal vein
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anticoagulation TherapyThe AC group were injected nadroparin calcium subcutaneously every 12 hours. Those who have serious varies or variceal bleeding can started AC therapy after endoscopic therapy. AC drugs was discontinued 3 days before endoscopic treatment. The control group did not administered any AC drugs. | Drug | anticoagulation group |
Primary outcome
rate of major bleeding
Time frame: 6-month
1-month,3-month,6-month major bleeding
mortality
Time frame: 6-month
1-month,3-month,6-month all-cause mortality
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 2 Nov 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Thrombocytopenia Related to Chronic Liver Disease and Anticoagulation Treatment, run by Qilu Hospital of Shandong University 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 5 inclusion and 7 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 2 Nov 2026. 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?
rate of major bleeding (time frame: 6-month). The study lists 2 primary outcomes in all. 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 2 Nov 2026.