RecruitingNot ApplicableNCT03647852

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura


Sponsor

Children's Hospital of Fudan University

Enrollment

150 participants

Start Date

Sep 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 2 YearsMax Age: 16 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called IVIG, a drug called Methylprednisolone, and others for people with henoch-schönlein purpura. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 2 Years to 16 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMethylprednisolone

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

DRUGIVIG

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

DRUGother 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

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NCT03647852


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