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临床试验/CTRI/2025/03/081827
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

ICMR1 个研究点 分布在 1 个国家目标入组 918 人开始时间: 2025年3月15日最近更新:

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

发起方
ICMR
申办方类型
Government funding agency
责任方
Principal Investigator
主要研究者

Rachana

Kasturba Medical College, Manipal

研究点 (1)

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