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

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

Detailed Description
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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.

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

Conditions
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Henoch-Schoenlein Purpura

Intervention / Treatment
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* Drug: Dexamethasone
* Drug: Gamma globulin
* Procedure: Hemoperfusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days Exclusion Criteria: The children with congenital diseases

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group 1<br>Dexamethasone 0.5mg/kg.d i.v. | Drug: Dexamethasone<br> <br> |
| Experimental: group 2<br>Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg | Drug: Dexamethasone<br> <br> Drug: Gamma globulin<br> <br> |
| Experimental: group 3<br>Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days | Drug: Dexamethasone<br> <br> Procedure: Hemoperfusion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Symptoms of Digestive Tract | The stomachache and other symptoms of digestive tract disappear | 2 weeks | 
| The Symptoms of Joint System | The arthralgia disappears | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Skin Rash | The Skin Rash disappears | 2 weeks | 
| Renal function | There is no damage in kidney. | 2 weeks |