Safety of Anticoagulation Therapy in Cirrhotic Patients With PVT and Severe Thrombocytopenia

NCT07885969 | Completed FDA Drug

• 1 other identifier: 20261013-Qilu
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thrombocytopenia Related to Chronic Liver Disease; Anticoagulation Treatment; Safety; Portal Vein Thrombosis

Keywords

Thrombocytopenia; Anticoagulation; Liver cirrhosis; Portal vein thrombosis; Safety

Outcome Measures

Primary Outcomes (2)

• rate of major bleeding

  1-month,3-month,6-month major bleeding

  6-month

• mortality

  1-month,3-month,6-month all-cause mortality

  6-month

Study Arms (2)

anticoagulation group

cirrhotic patients with PVT receiving anticoagulation therapy

Drug: Anticoagulation Therapy

the control group

cirrhotic patients with PVT not receiving AC therapy

Interventions

Anticoagulation Therapy DRUG

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.

anticoagulation group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• (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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Liaocheng People's Hospital: collaborator
• Taian City Central Hospital: collaborator

Study Sites (1)

Qilu Hosipital of Shandong University

Jinan, Shandong, 250000, China

Location

MeSH Terms

Conditions

Thrombocytopenia; Liver Cirrhosis

Interventions

Anticoagulation Bridge

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bridge Therapy; Therapeutics

Study Design

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

Study Record Dates

• First Submitted: October 14, 2026
• First Posted: October 21, 2026
• Study Start: September 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 21, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)