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CompletedNCT02546414Updated Sep 10, 2015

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

An observational study in Platelet Count/Spleen Diameter Ratio and Child-Pugh Classification, sponsored by RenJi Hospital. Completed at 1 site in China. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2015-09-10.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
150
Ages
45 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Platelet Count/Spleen Diameter Ratio
  • Child-Pugh Classification

Keywords

  • Platelet count/spleen diameter ratio
  • China
03

In context

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HBV cirrhotic patients in China

Inclusion criteria

  • Patients with a diagnosis of HBV hepatic cirrhosis

Exclusion criteria

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
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
150 participants (actual)
Patient registry
No

Groups and cohorts

  • Esophageal varices haemorrhage group

    HBV hepatic cirrhosis with first esophageal varices haemorrhage were included and stratified using their Child-Pugh score. The platelet count were evaluated, and ultrasound was used to measure the longest diameter of the spleen. The platelet count(PC)/spleen diameter (SD)ratio was calculated and analyzed to determine whether it can predict the variceal haemorrhage. Upper gastrointestinal endoscopy was used as the gold standard.

    Other: Platelet count/spleen diameter ratio

  • no haemorrhage but esophageal varice presence

    HBV hepatic cirrhosis with no esophageal varices haemorrhage were included and upper gastrointestinal endoscopy were validate.They also stratified using their Child-Pugh score. The platelet count and longest diameter of the spleen were evaluated, The PC/SD ratio was calculated and analyzed to determine whether it can predict the variceal presence.

    Other: Platelet count/spleen diameter ratio

  • no esophageal varice but cirrhotic

    HBV hepatic cirrhosis with no esophageal varices were included and also validated by upper gastrointestinal endoscopy.They stratified using their Child-Pugh score. The platelet count and longest diameter of the spleen were evaluated,The PC/SD was calculated and analyzed to determine whether it can predict the variceal absence .

    Other: Platelet count/spleen diameter ratio

Interventions

  • OtherPlatelet count/spleen diameter ratio

    Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated

    Also known as: PC/SD ratio

06

What researchers measure

Primary outcomes

  1. Platelet count/spleen diameter ratio

    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

    Time frame: up to 2.5 years

Secondary outcomes

  1. Child-Pugh score.

    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

    Time frame: up to 2.5 years

07

Study locations

1 site
  • Renji Hospital
    Shanghai, Shanghai, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02546414
Lead sponsor
RenJi Hospital
Responsible party
Shengliang Chen (MD, RenJi Hospital) — Principal investigator
First posted
Sep 10, 2015
Start date
Jan 2013
Primary completion
Jul 2015
Completion
Aug 2015
Last update
Sep 10, 2015

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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