Clinical Study on Strategy for Refractory Henoch-Sch nlein Purpura

  • STATUS
    Recruiting
  • days left to enroll
    12
  • participants needed
    150
  • sponsor
    Children's Hospital of Fudan University
Updated on 26 January 2021

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.

Details
Condition Allergic Purpura
Treatment Methylprednisolone, IVIG, other basic supportive treatment
Clinical Study IdentifierNCT03647852
SponsorChildren's Hospital of Fudan University
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

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
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