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
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; (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
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.
- 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
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No