跳至主要内容
临床试验/NCT03935360
NCT03935360已完成不适用

External Validation of a Prognostic Risk Score for Safe Discharge Among Patients With Lower Gastrointestinal Bleeding: A Prospective Multi-centre Cohort Study

Lawson Health Research Institute6 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2019年11月25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
344
试验地点
6
主要终点
Discrimination of the Oakland-Jairath score for predicting safe discharge

研究概览

简要总结

Lower gastrointestinal bleeding (LGIB) is a common presentation in the Emergency Room. It can deteriorate into severe adverse event. However some are discharged before these events occur. The Oakland-Jairath score was developed to help determine which patients can be safely discharged and which should be admitted from the ER to the hospital. The score did well in its development, but now needs to be externally validated by other independent cohorts. The limitations of the first study will be addressed in our study. The goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB.

详细描述

Of critical importance in the approach to care of these patients is differentiating the majority of people who can be safely discharged for outpatient management from those who are at risk for serious adverse events and require hospitalization. Recently, Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. The next step in the development of a clinical prediction rule is external validation in independent cohorts. Measures of predictive accuracy for risk scores, such as the AUC, are overly optimistic when calculated from the derivation cohort from which the risk score was derived. Therefore, it is essential to evaluate its performance using independent and diverse validation cohorts. Thus, the goal of this study is to perform the first prospective, multi-centered, external validation of the Oakland-Jairath risk score on an independent and diverse population who present to the emergency room with LGIB. This is a prospective multi-centre observational study to externally validate the Oakland-Jairath LGIB risk score, herein referred to simply as the "risk score".

Consecutive patients presenting to hospital over a 6 month period will have their risk score calculated and followed for the development of an adverse outcome over a 28 day period. The risk score will be determined for research purposes only but will be shared with the treating physician if requested as the details of the risk score itself is within the public domain. Patients will be eligible regardless of discharge status and all admission decisions will be made solely by the treating physicians. To increase the diversity of the validation cohort, increase generalizability, and hasten recruitment, the study will be conducted at 4 centres: Western University, University of Alberta, University of Montreal, and McGill University.

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

  • Presenting complaint of LGIB, defined as any of the following:
  • Bright red blood per rectum
  • Maroon coloured stool
  • Criteria A and B applies regardless if the blood is seen without stool, with stool of any consistency, or only on the toilet paper

排除标准

  • Hematemesis, defined as bright blood or coffee ground emesis
  • Patients who developed LGIB while already admitted to hospital for any reason
  • Patients transferred between hospitals
  • Failure to obtain informed consent
  • Occult bleeding, defined as the presence of a positive FOBT/FIT or iron deficiency anemia in the absence of bright red blood per rectum or maroon coloured stool
  • Perceived inability to contact the subject by telephone or e-mail for the 28 day follow up assessment

结局指标

主要结局

Discrimination of the Oakland-Jairath score for predicting safe discharge

时间窗: 28 days after enrollment

Discrimination, defined as the ability of the prediction model to differentiate between those who develop and do not develop the outcome event of interest, as measured by the c-statistic, and calibration, defined as the agreement between predicted and observed outcomes, measured by a calibration plot, of the Oakland-Jairath score for predicting safe discharge, defined as the absence of ALL of the following: i. Rebleeding, defined as \[additional blood transfusions\] or \[a further decrease in hematocrit concentration of 20% or more\], both after 24h clinical stability ii. Readmission for LGIB within 28 days iii. Red blood cell transfusion iv. Therapeutic intervention for hemostasis (endoscopic/IR/surgery) v. Death within 28 days

次要结局

  • Discrimination of the Oakland-Jairath score compared to pre-existing LGIB risk scores(28 days after enrollment)
  • Discrimination of the Oakland-Jairath score compared to traditional UGIB risk scores(28 days after enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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