Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-16
SponsorChildren's Hospital of Fudan University

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.

Eligibility criteria

Qualifiers

both genders

age between 2-16 years old

IgA vasculitis with gastrointestinal involvement

course of disease less than 2 months

Disqualifiers

patients with severe sepsis

patients with central nervous system infection,

patients with severe pneumonia

patients with chronic infection (such as EBV, CMV, Tuberculosis)

Trial design

Treatments tested in this trial

  • Methylprednisolone
  • IVIG
  • other basic supportive treatment

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Children's Hospital of Fudan University

Lead sponsor

Shanghai Children's Hospital

Collaborator

Shanghai Children's Medical Center

Collaborator