Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Study Overview
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Brief Summary
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IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.

Official Title
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Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Conditions
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Henoch-Schönlein Purpura

Intervention / Treatment
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* Drug: Methylprednisolone
* Drug: IVIG
* Drug: other basic supportive treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both genders age between 2-16 years old IgA vasculitis with gastrointestinal involvement course of disease less than 2 months refractory to ordinary dosage of prednisolone (less than 2mg/kg/d） Exclusion Criteria: patients with severe sepsis patients with central nervous system infection, patients with severe pneumonia patients with chronic infection (such as EBV, CMV, Tuberculosis) patients complicated by CKD who need renal replacement therapy patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylprednisolone group<br>In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d) | Drug: Methylprednisolone<br>* 1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change<br>Drug: other basic supportive treatment<br>* Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day Low molecular weight heparin calcium 50IU/kg.d<br>|
| Active Comparator: IVIG group<br>In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d) | Drug: IVIG<br>* 1. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days<br>Drug: other basic supportive treatment<br>* Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day Low molecular weight heparin calcium 50IU/kg.d<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained abdominal pain relief | no abdominal pain complaint and no abdominal tenderness | 3 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sustained abdominal pain relief | 3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment | 7 days after treatment | 
| other treatment rather than assigned intervention | other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed | 4 weeks after treatment | 
| tolarable food type | what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid ) | 2 weeks after treatment | 
| the number of days of taking fasting | the number of days of taking fasting will be counted at the time of discharge | At the time of discharge | 
| Drug-related side effects | Side effects associated with methylprednisolone and IVIG will be recorded | 3 days after treatment | 
| hypertension | systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor. | 7 days after treatment | 
| infection | different infection types should be specified | 4 weeks after treatment | 
| ocular hypertension | 1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg | 7 days after treatment | 
| steroid-related diabetes | 1. with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l | 3 days after treatment | 
| cost of treatment | cost of treatment will be obtained from discharge fee list | 4 weeks after treatment | 
| The number of days in hospital | The number of days in hospital will be counted at the time of discharge | at the time of discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe gastrointestinal involvement