CTRI/2025/03/081827招募中3 期
Development, validation and real-world impact of bleeding prediction models for optimizing transfusion therapy in Dengue
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ICMR
- 入组人数
- 918
- 试验地点
- 1
- 主要终点
- Bleeding (except petechiae & minor mucosal bleed)
研究概览
简要总结
The study will be a diagnostic randomised trial. A bleeding prediction tool to predict 48-hour bleeding in Dengue. The treating Physician in the Diagnostic intervention arm will be given the bleeding prediction tool, the control group will not be provided the bleeding prediction tool and will receive the standard of care as per the treating physician. The incidence of 48 hour bleeding, blood product transfusion practices will be noted. The bleeding prediction tool will be validated and its real-world impact and physician acceptance will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients presenting with Fever with Thrombocytopenia and having positive Dengue card test (NS1/IgM) on screening.
排除标准
- •Known coagulation disorder Patient on anticoagulant medications Patients with active bleeding at the time of admission.
结局指标
主要结局
Bleeding (except petechiae & minor mucosal bleed)
时间窗: 48 hours from recruitment
次要结局
- Blood Product transfusion (RDP)(48 hours from recruitment)
研究者
Rachana
Kasturba Medical College, Manipal
研究点 (1)
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