Platelet Count（PC）/Spleen Diameter(SD) Ratio to Predict the Variceal Haemorrhage in HBV Cirrhotic Patients in China

Completed

• Conditions: Child-Pugh Classification; Platelet Count/Spleen Diameter Ratio

• Registration Number: NCT02546414
• Lead Sponsor: RenJi Hospital

Brief Summary

To validate the PC/SD ratio to be used to predict the variceal haemorrhage in Chinese patients with hepatitis B virus (HBV)-associated hepatic cirrhosis.

Detailed Description

Esophageal variceal bleeding remains the leading cause of acute mortality in patients with cirrhosis. Using noninvasive parameters for high-risk variceal haemorrhage may reduce the need for endoscopies. The ratio of platelet count/diameter of the spleen (PC/SD ratio) is the principal noninvasive predictor of esophageal varices. This was an analytical cross-sectional study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between January 2013 and August 2015. This study is to validate the PC/SD ratio to identification of those patients with high bleeding risk and selection for prophylactic treatment.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2015-07
• Study Completion: 2015-08
• Study First Submitted: 2015-08-26
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-08
• Last Update Submitted: 2015-09-08
• Study First Posted: 2015-09-10
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients with a diagnosis of HBV hepatic cirrhosis

Exclusion Criteria

• Patients with hepatocellular carcinoma,
• use of medications for the primary prophylaxis of variceal bleeding,
• history of esophageal variceal bleeding,
• alcohol consumption within the admission and a history of ligation,
• sclerotherapy, and/or
• portal hypertension surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Platelet count/spleen diameter ratio	up to 2.5 years	This was an analytical cross-sectional study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between January 2013 and August 2015

Secondary Outcome Measures

Name	Time	Method
Child-Pugh score.	up to 2.5 years	This was an analytical cross-sectional study to validate the diagnostic test for HBV hepatic cirrhosis and was performed between January 2013 and August 2015

Trial Locations

Locations (1)

Renji Hospital; 🇨🇳 Shanghai, Shanghai, China