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临床试验/NCT06325436
NCT06325436尚未招募不适用

Accuracy of Simple Objective Scores in Prediction of Short-Term Outcome Among Cirrhotic Patients With Variceal Bleeding

Assiut University0 个研究点目标入组 85 人开始时间: 2024年3月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
85
主要终点
assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding.

研究概览

简要总结

To assess the prognostic performance of the ALBI associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.

详细描述

Acute variceal bleeding is the most common feature of decompensation in patients with cirrhosis and one of the life-threatening complications, causing significant morbidity and mortality in patients with cirrhosis 2,3.

Although much progress has been made in diagnosis and treatment the 6-week mortality rate remains high, ranging from 10 to 20%, mainly due to failure to control bleeding in the first days 4-5.

It is therefore critical to develop a prognostic method for patients with acute variceal bleeding to determine the risk of re-bleeding 6 and resistance to standard treatment (accounting for 20-30%) 7 and death to adopt more aggressive treatment measures.

Many existing scoring systems have been used to evaluate the prognosis of patients with variceal bleeding, but none of them are targeted: including the Child-Pugh score, Model for End-Stage Liver Disease (MELD), and MELD-Na, clinical Rockall score (CRS), AIMS65 score (AIMS65), and Glasgow-Blatchford score (GBS) 9-11 However, these scores have the limitation that some information is subjective, and they use several tests that are less specific for liver disease, meaning that the best method to stratify risk of re-bleeding and morality among cirrhotic patients is still not clear.

In recent years, some new scores have been introduced. One of these scoring systems is the serum albumin and total bilirubin (ALBI) score that was developed to assess outcome in patients with hepatocellular carcinoma (HCC) and primary biliary cholangitis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Any cirrhotic patients above the age of 18 years old of both sexes, present with variceal bleeding.

排除标准

  • Patients with other causes of upper gastrointestinal bleeding (UGIB).
  • Patients who are receiving anticoagulant or antiplatelet therapy.
  • Patients with HCC, other malignant tumors, and hematological disease at the time of recruitment or during follow up.
  • Patients who underwent transjugular intrahepatic portosystemic shunt, splenectomy, or partial splenic embolization.
  • Patients with liver cirrhosis and portal vein thrombosis.

结局指标

主要结局

assess the prognostic performance of the ALBI_associated scores and new MELD .3 in predicting the short-term outcomes of patients with cirrhosis presenting with acute variceal bleeding.

时间窗: baseline

assess the prognostic performance of the ALBI_associated scores (ALBI, PALBI and INR-ALBI score) and new MELD .3 in predicting the short-term outcomes (early re-bleeding and early mortality) of patients with cirrhosis presenting with acute variceal bleeding, comparable to the CTP and MELD and MELD Na scores.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rawnaa Hosny Ammar

Resident doctor

Assiut University

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Objective Scores in Variceal Bleeding | 临床试验