Risk Factors for Hospitalization and Transfusion Criteria in Patients With Dengue Virus Infection: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Proportion of enrolled patients requiring hospitalization
研究概览
简要总结
This 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. It also seeks to analyze real-world transfusion practices and their outcomes. The study will be conducted in a second-level hospital in northern Mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.
详细描述
This study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. It seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors.
Patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. Clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.
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
- 5 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥5 years
- •Laboratory-confirmed dengue infection (NS1, IgM, or PCR)
- •First contact at emergency or outpatient services
- •Informed consent signed by the patient or legal guardian
排除标准
- •Co-infection with other arboviruses or COVID-19
- •Pre-existing hematologic or oncologic disease
- •Refusal to sign informed consent
结局指标
主要结局
Proportion of enrolled patients requiring hospitalization
时间窗: Time Frame: Within 10 days of symptom onset
The proportion of patients with laboratory-confirmed dengue infection who require hospitalization will be recorded. Hospitalization is defined as admission to the inpatient ward or intensive care unit for ≥24 hours due to dengue-related clinical indications. Unit of Measure: Percentage of participants (%)
Clinical and laboratory risk factors associated with hospitalization
时间窗: Within 10 days of symptom onset
Description: Among patients who are hospitalized, relevant clinical signs (e.g., persistent vomiting, mucosal bleeding, abdominal pain) and laboratory parameters (e.g., platelet count, hematocrit rise, leukopenia) will be analyzed to identify independent predictors for hospitalization using multivariate regression. Unit of Measure: Odds ratio for each factor (as determined by statistical modeling)
次要结局
- Proportion of patients receiving blood product transfusion(Time Frame: Within 14 days)
- Criteria for transfusion used by attending physicians(Within 14 days of symptom onset)
研究者
Jose Ivan Rodriguez de Molina Serrano
Head of Research and Medical Education Clinica Mexico
Clinica Mexico