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临床试验/NCT06409988
NCT06409988已完成不适用

External Validation of the SHA2PE Score and Its Comparison to the Oakland Score for the Prediction of Safe Discharge in Patients With Lower Gastrointestinal Bleeding

Germans Trias i Pujol Hospital1 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
398
试验地点
1
主要终点
Validation of SHA2PE score in our cohort

研究概览

简要总结

The increasing incidence in lower gastrointestinal bleeding (LGIB) leads to a rise in hospital admission. Many LGBI are self-limiting thus the several scores to identify low risk patients suited to outpatient care have been described. We aim to compare two of this scores (Oakland score and SHA2PE score) in terms of performace to predict "safe discharge" from the emergency department.

详细描述

The growing incidence of lower gastrointestinal bleeding (LGIB) is leading to a rise in hospital admissions even though most LGIB episodes are self-limiting. The Oakland and SHA2PE scores were designed to identify patients best suited to outpatient care. Our aim is to validate the SHA2PE score and compare both of these scores in terms of predictiveness of safe discharge.

We conducted a retrospective observational study of LGIB patients admitted to our hospital between June 2014-June 2019. During this period, data from all LGIB episodes admitted from the ED were collected in an electronic anonymized database created specifically for this study. If any of the principal variables or critical information was missing, the patient was excluded from the study.

研究设计

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

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

  • All > 18 year old patients, male and women, admitted to our hospital between June 2014 and June 2019 because of LGIB (lower gastrointestinal bleeding).

排除标准

  • Patients in whom LGIB occurred while already admitted for an other cause.
  • Patients with LGIB transferred from another hospital due to comorbidities or severity of the gastrointestinal bleeding episode.
  • Patients with post-polypectomy LGIB (endoscopic polypectomy <14 days before admission).
  • Patients with gastrointestinal bleeding of unknown origin after a complete study.
  • Patients who had undergone digestive tract surgery in the previous month.
  • Patients with an ostomy.
  • Patients with known colorectal cancer who had not undergone surgery.

结局指标

主要结局

Validation of SHA2PE score in our cohort

时间窗: After 1 month of follow-up from the hospital discharge

We aim to validate this score in a southern Europe cohort and compare it to the Oakland score

Safe Discharge

时间窗: After 1 month of follow-up from the hospital discharge

Patients with lower gastrointestinal bleeding and absence of all the following: rebleeding, re-consulting for LGIB within 28 days after discharge, in-hospital mortality, requirement of red blood cell transfusion or endoscopic, radiological, or surgical haemostatic treatment.

次要结局

  • Performance of SHA2PE score in safe discharge(After 1 month of follow-up from the hospital discharge)
  • Performance of Oakland score in safe discharge(After 1 month of follow-up from the hospital discharge)

研究者

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

Laura Gonzalez

Laura González González

Germans Trias i Pujol Hospital

研究点 (1)

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