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临床试验/CTRI/2024/07/071421
CTRI/2024/07/071421尚未招募不适用

Evaluation of pro-thrombotic factors in children and adolescents hospitalized with a relapse of nephrotic syndrome

Department of Pediatrics Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
40
试验地点
1
主要终点
Proportion of patients with altered levels of antithrombin III, Protein C, Protein S

研究概览

简要总结

This cross-sectional study will be conducted in the Department of Pediatrics at Maulana Azad Medical College and associated Lok Nayak Hospital, New Delhi includes 40 children and adolescents aged 2-18 years hospitalized with a relapse of nephrotic syndrome. This study aimed to determine the proportion of children and adolescents with nephrotic syndrome having altered prothrombotic factors with disease relapse. The primary objective is to measure levels of antithrombin III, Protein C, Protein S in children and adolescents hospitalized with a relapse of nephrotic syndrome (both steroid sensitive and steroid resistant nephrotic syndrome ) at admission and at discharge / 2 weeks whichever is earlier. As children with complicated relapses need hospitalization for treatment and more likely to be predisposed to thromboembolism , we decided to study factors contributory for development of thromboembolism.

研究设计

研究类型
Observational

入排标准

年龄范围
2.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Children and adolescents hospitalized with a relapse of nephrotic syndrome.

排除标准

  • Presence of concomitant acute hepatitis/ liver disease
  • Already on anticoagulants
  • Patients admitted for renal biopsy
  • Congenital nephrotic syndrome.

结局指标

主要结局

Proportion of patients with altered levels of antithrombin III, Protein C, Protein S

时间窗: At admission and at discharge /2 weeks of hospitalization whichever is earlier

次要结局

  • Proportion of patients with altered coagulation profile parameters (PT/INR/aPTT/Platelet count)(At admission and at discharge /2 weeks of hospitalization whichever is earlier)
  • Proportion of patients with altered D-Dimer, Fibrinogen and FDP(At admission and at discharge /2 weeks of hospitalization whichever is earlier)
  • Proportion of patients with presence of Factor V Leiden mutation(At admission and at discharge /2 weeks of hospitalization whichever is earlier)
  • Association of Prothrombotic factors with disease type, duration, therapy, presence of infection and hypovolemia(At admission and at discharge /2 weeks of hospitalization whichever is earlier)

研究者

发起方
Department of Pediatrics Maulana Azad Medical College
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mansi Gupta

Maulana Azad Medical College

研究点 (1)

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