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临床试验/NCT04235166
NCT04235166Unknown不适用

A Simple Risk Score to Assess Prognosis of Acute Upper Gastrointestinal Bleeding in Cirrhosis

Affiliated Hospital to Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Mortality within 42 days

研究概览

简要总结

In previous studies, the investigators used retrospective analysis of cases of acute upper gastrointestinal bleeding in patients with liver cirrhosis from the Fifth Medical Center of the General Hospital of Beijing PLA, China from January 2018 to May 2019. The investigators performed univariate and multivariate analyses of rebleeding risk and death risk based on all data. Then, based on the analysis of 85% of the sampled data, the investigators randomly selected 85% of the patient data to build a model, and then used the remaining 15% of the patient data for model validation. Re-bleeding risk scores and death risk scores were established, respectively.

This study intends to prospectively verify the two risk scoring systems described above. After statistical calculations, about 500 patients with liver cirrhosis who plan to undergo emergency gastroscopy for acute upper gastrointestinal bleeding within the next 5 months at the Fifth Medical Center of Beijing General Hospital of China performed in adult patients. The investigators will exclude patients with incomplete or lost follow-up records. Perform patient self-control,using the existing upper gastrointestinal bleeding risk scores (AIMS65, Rockall, and Blatchford) and the previous scoring system model separately, compared with the actual rebleeding rate and mortality for comparison. To verify and revise the rebleeding risk score and death risk score that the investigators constructed earlier.The data were statistical processed by a professional statistician.

The establishment of an acute upper gastrointestinal bleeding rebleeding and death risk scoring system for patients with liver cirrhosis can help distinguish patients with high or low risk of rebleeding or death to determine the patient's treatment needs.

详细描述

In previous studies, the investigators used retrospective analysis of cases of acute upper gastrointestinal bleeding in patients with liver cirrhosis from the Fifth Medical Center of the General Hospital of Beijing PLA, China from January 2018 to May 2019. The survey and return visits were completed by the patient's clinician, and the subject researcher was responsible for reviewing and including a complete questionnaire for eligible patients. The database includes demographic information, vital signs and other key clinical manifestations, endoscopic findings, laboratory test results, imaging studies and complications, and rebleeding and deaths within 42 days. Covers known risk factors for rebleeding and death.

First, the investigators performed univariate and multivariate analyses of rebleeding risk and death risk based on all data. Second, based on the analysis of 85% of the sampled data, the investigators randomly selected 85% of the patient data to build a model, and then used the remaining 15% of the patient data for model validation. Re-bleeding risk scores and death risk scores were established respectively.

This study intends to prospectively verify the two risk scoring systems described above. After statistical calculations, about 500 patients with liver cirrhosis who plan to undergo emergency gastroscopy for acute upper gastrointestinal bleeding within the next 5 months at the Fifth Medical Center of Beijing General Hospital of China Performed in adult patients. the investigators will exclude patients with incomplete or lost follow-up records. One researcher was responsible for patient identification and data collection during the initial review, and one researcher performed subsequent data entry, which was statistical processed by a professional statistician.

Perform patient self-control,using the existing upper gastrointestinal bleeding risk scores (AIMS65, Rockall, and Blatchford) and the previous scoring system model separately, compared with the actual rebleeding rate and mortality for comparison. To verify and revise the rebleeding risk score and death risk score that the investigators constructed earlier.

The establishment of an acute upper gastrointestinal bleeding rebleeding and death risk scoring system for patients with liver cirrhosis can help distinguish patients with high or low risk of rebleeding or death to determine the patient's treatment needs.

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

  • Patients with histologically proven cirrhosis or clinical and ultrasonographic data compatible with the diagnosis of cirrhosis
  • Above 18 years old patients
  • Clinical evidence of bleeding (hematemesis and/or melena) during the previous 24 hours
  • Undergo the emergency endoscopy within 2 hours at admittance to emergency room or in the general ward from the initial evaluation
  • Who agree to participate in the study

排除标准

  • Unfit for resuscitation
  • Pregnancy and lactation

结局指标

主要结局

Mortality within 42 days

时间窗: 42 days

Mortality within 42 days were calculated.

次要结局

  • Rebleeding rate within 42 days(42 days)

研究者

发起方
Affiliated Hospital to Academy of Military Medical Sciences
申办方类型
Other
责任方
Sponsor

研究点 (1)

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