Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

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.

Conditions

• Henoch-Schönlein Purpura

Interventions

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

Sponsors & Collaborators

• Shanghai Children's Hospital

  collaborator OTHER

• Shanghai Children's Medical Center

  collaborator OTHER

• Children's Hospital of Fudan University

  lead OTHER

Principal Investigators

• Li Sun, MD · Children's Hospital of Fudan University

• Wenyan Huang, MD · Shanghai Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-09-01

Primary Completion

2026-02-27

Completion

2026-10-30

Countries

• China

Study Locations