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Completed

NCT Number: NCT05541562

A Practical Nomogram Based on Systemic Inflammatory Markers for Predicting Portal Vein Thrombosis in Patients With Liver Cirrhosis

Immunothrombosis has recently been used to describe the responses/mechanisms in thrombosis. Systemic inflammatory markers are prognostic markers for a variety of thrombotic conditions; however, their potential value in predicting portal vein thrombosis (PVT) is unknown. This study aimed to establish an easy-to-use nomogram based on systemic inflammatory markers to predict portal vein thrombosis (PVT) in patients with liver cirrhosis.

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Key information

Age range

18 year–81 year

Sex eligibility

All sexes

Study type

Observational

Primary location

the Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

About this study

This retrospective study included 478 patients with cirrhosis between January 2013 and January 2021. Reputed systemic inflammatory markers (systemic immune-inflammation index [SII], neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], and platelet-to-lymphocyte ratio (PLR)) were measured, and the clinical data were recorded. The independent risk factors for PVT were determined using univariate analyses and multivariate logistic regression analyses, and a nomogram to predict the occurrence of PVT was established. The concordance index, receiver operating characteristic curves, and calibration plots were used to evaluate the performance of the model.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

The diagnosis of LC was based on clinical, laboratory, and radiological analyses, and/or liver biopsies. PVT was diagnosed according to the consensus for management of PVT in LC (2020, Shanghai) [1]. The inclusion criteria were as follows: (I) age ≥18 years, (II) Doppler ultrasound was the first-choice imaging modality; however, enhanced computed tomography or magnetic resonance imaging could also be used for confirmation at the time of admission to our hospital, and (III) patients with PVT on imaging examination but with insufficient evidence for the diagnosis of cirrhosis, hepatic vein pressure gradient measurement, and liver biopsy. -

Exclusion criteria

Patients with primary or secondary hepatic malignant tumors, other malignant tumors, hematologic diseases, Budd-Chiari syndrome, non-cirrhotic PVT, inflammatory diseases, and other severe diseases were excluded.

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Treatment and study plan

clinical laboratory tests, and imaging characteristics

Diagnostic Test

Data included the demographic status, etiology of the liver disease, clinical laboratory tests, and imaging characteristics. Clinical laboratory tests included D-dimer, activated partial thromboplastin time (APTT), prothrombin time (PT), antithrombin III, international normalized ratio (INR), thrombin time (TT), albumin (Alb), serum creatinine, hemoglobin, platelet count, white blood cell count, neutrophil count, lymphocyte count, monocyte count, model for end-stage liver disease (MELD) score, and Child-Pugh score. Imaging characteristics included splenic vein diameter, splenic vein velocity, portal vein diameter, and portal vein velocity.

Primary outcomes

  1. systemic inflammatory markers

    Time frame: 9 years

    systemic immune-inflammation index [SII], neutrophil-to-lymphocyte ratio [NLR], monocyte-to-lymphocyte ratio [MLR], and platelet-to-lymphocyte ratio (PLR)

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Sep 15, 2022
Registry last updated
Sep 15, 2022

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.

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