An observational study in Thrombocytopenia Related to Chronic Liver Disease, Anticoagulation Treatment and Safety, sponsored by Qilu Hospital of Shandong University. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Qilu Hospital of Shandong University · Observational
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.
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.
703 studies on the registry are indexed under Thrombocytopenia; 150 are open to participants now.
This study's enrollment of 304 is above the median of 120 across 186 observational studies indexed under Thrombocytopenia.
Browse Thrombocytopenia studies →Qilu Hospital of Shandong University is the lead sponsor of 305 studies on the registry; 184 are open to participants now.
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cirrhotic patients with PVT were assigned to either the AC group or the control group in accordance with receiving AC therapy or not
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(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
Exclusion Criteria:
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.
cirrhotic patients with PVT receiving anticoagulation therapy
Drug: Anticoagulation Therapy
cirrhotic patients with PVT not receiving AC therapy
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.
rate of major bleeding
1-month,3-month,6-month major bleeding
Time frame: 6-month
mortality
1-month,3-month,6-month all-cause mortality
Time frame: 6-month
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Dec 2025, 3 months.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University →