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RECRUITINGINTERVENTIONAL

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. both genders 2. age between 2-16 years old 3. IgA vasculitis with gastrointestinal involvement 4. course of disease less than 2 months 5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d） Who Should NOT Join This Trial: 1. patients with severe sepsis 2. patients with central nervous system infection, 3. patients with severe pneumonia 4. patients with chronic infection (such as EBV, CMV, Tuberculosis) 5. patients complicated by CKD who need renal replacement therapy 6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. both genders 2. age between 2-16 years old 3. IgA vasculitis with gastrointestinal involvement 4. course of disease less than 2 months 5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d） Exclusion Criteria: 1. patients with severe sepsis 2. patients with central nervous system infection, 3. patients with severe pneumonia 4. patients with chronic infection (such as EBV, CMV, Tuberculosis) 5. patients complicated by CKD who need renal replacement therapy 6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

Treatments Being Tested

DRUG

Methylprednisolone

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

DRUG

IVIG

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

DRUG

other basic supportive treatment

1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d

Locations (3)

Children's Hospital of Fudan University
Shanghai, China
Children's Hospital of Shanghai
Shanghai, China
Shanghai Children's Medical Centre
Shanghai, China