跳至主要内容
临床试验/NCT07089277
NCT07089277招募中不适用

External Validation of the Glasgow-Blatchford Bleeding Score in a Tunisian Population

Hôpital Universitaire Sahloul1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2024年1月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days

研究概览

简要总结

This study aims to externally validate the Glasgow-Blatchford Score (GBS) in a Tunisian population presenting with non-traumatic upper gastrointestinal bleeding. Despite advances in endoscopic management, early risk stratification remains essential to guide clinical decision-making. In Tunisia, the routine hospitalization of all patients for observation presents a challenge, highlighting the need for reliable prognostic tools.

The study is designed as a multicenter, descriptive, and analytical investigation across several emergency departments. Adult patients (≥16 years) will be included, with follow-up conducted at 30 days to assess for adverse outcomes including rebleeding, the need for hemostasis, complications, and mortality.

Clinical and epidemiological data will be collected using a standardized form. Statistical analysis will evaluate the predictive performance of the GBS, focusing on sensitivity, specificity, and predictive values for 30-day outcomes.

The results are expected to determine whether GBS is a valid and useful tool for risk assessment in the Tunisian context, potentially aiding in more efficient and targeted patient management.

详细描述

Introduction:

Acute gastrointestinal bleeding is a common reason for emergency department visits and is associated with significant morbidity and mortality. The emergency physician plays a crucial role in rapid diagnosis, risk stratification, and appropriate management [1]. Although the incidence of gastro-duodenal ulcers has decreased in recent years, they remain the most frequent cause of upper gastrointestinal bleeding [2].

Diagnostic and therapeutic approaches have significantly improved, particularly with the wider availability of endoscopy. However, early assessment of bleeding severity and prognostic risk remains essential in patient management. Several prognostic scoring systems have been proposed, but few have been validated or widely adopted in clinical practice [2].

In Tunisia, as in many developing countries, a major challenge is the routine hospitalization of all patients for monitoring, although only a subset will develop complications. The use of prognostic scores such as the Glasgow-Blatchford Score could allow for better identification of at-risk patients and more targeted therapeutic strategies [3-4].

The Glasgow-Blatchford Score (GBS) is a widely used predictive tool for assessing the risk of severe complications in patients with upper gastrointestinal bleeding. However, its performance and validity have been minimally studied in the Tunisian population. This study aims to validate the Glasgow-Blatchford Score in a Tunisian cohort to confirm its relevance and utility in a local clinical context [5-7].

研究设计

研究类型
Observational
观察模型
Other
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

  • Adult patients (≥18 years) presenting with non-traumatic upper gastrointestinal bleeding

排除标准

  • patients under 18 years of age.
  • Diagnosis of external hemorrhoids with mucosal lesions.
  • Patients who do not consent, are lost to follow-up, or have incomplete data.

结局指标

主要结局

adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days

时间窗: 30 days

adverse outcomes such as rebleeding, the need for hemostatic intervention, complications and mortality at 30 days

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

Riadh Boukef

Riadh Boukef

Hôpital Universitaire Sahloul

研究点 (1)

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