Clinical Trial: The Research of Standard Diagnosis and Treatment for Severe HSP in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children

Brief Summary: This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.

Detailed Summary:

Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.

In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.

The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.


Sponsor: Nanjing Children's Hospital

Current Primary Outcome:

  • The Symptoms of Digestive Tract [ Time Frame: 2 weeks ]
    The stomachache and other symptoms of digestive tract disappear
  • The Symptoms of Joint System [ Time Frame: 2 weeks ]
    The arthralgia disappears


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The Skin Rash [ Time Frame: 2 weeks ]
    The Skin Rash disappears
  • Renal function [ Time Frame: 2 weeks ]
    There is no damage in kidney.


Original Secondary Outcome: Same as current

Information By: Nanjing Children's Hospital

Dates:
Date Received: August 20, 2015
Date Started: August 2015
Date Completion: July 2018
Last Updated: October 29, 2016
Last Verified: October 2016