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OpenTrials
Completed

NCT Number: NCT02546414

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

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.

Completed

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Key information

Conditions

Platelet Count/Spleen Diameter Ratio Child-Pugh Classification

Age range

45 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Renji Hospital

Shanghai, Shanghai Municipality, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Platelet count/spleen diameter ratio

Other

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

Other names: PC/SD ratio

Primary outcomes

  1. Platelet count/spleen diameter ratio

    Time frame: 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 outcomes

  1. Child-Pugh score.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2015
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.