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临床试验/NCT01443247
NCT01443247已完成不适用

Role of Andi-d in Dengue Fever: a Pilot Study

Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm

研究概览

简要总结

The purpose of this study is evaluate the role of anti-d in dengue fever.

详细描述

This study was conducted in pgimer. Patients presenting with fever and thrombocytopenia in emergency medical opd / medicine opd were screened and all dengue serology positive patients were evaluated for enrolment into the study. We had proposed to enroll 30 patients with diagnosed dengue haemorrhagic fever. the diagnosis of the dengue fever was based upon the clinical history ,general physical examination and the lab tests : thrombocytopenia ( platelet count ≤ 20,000 ) ,and a positive dengue serology.

STUDY DESIGN : It was an open label inteventional study . one group of 15 patients ( intervention group ) received platelet support along with injection anti-d in a dose of 50 µg/kg (250IU/kg) intravenously while the other group of 15 ( control group) received platelet support only . a base line platelet count of all the participant of both the study groups was taken and then the level of platelets at 12 , 24 , 36 , and 48hr post treatment initiation was noted. The patients were followed till the time of discharge .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

platelet support + anti-d

Experimental

干预措施: anti-d (Drug)

platelet support

No Intervention

干预措施: anti-d (Drug)

结局指标

主要结局

to see for the number of patients attaining a platelet count ≥ 50,000 /mm3 after 48 hours of administration of anti-d in the intervention arm

时间窗: 1 YEAR

次要结局

  • the difference in two study arms with respect to: total volume of platelet concentrate transfused , duration of hospital stay , & severity of haemorrhagic manifestations(1 YEAR)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Deepak Thakur

junior resident

Post Graduate Institute of Medical Education and Research, Chandigarh

研究点 (1)

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