Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylprednisolone, IVIG, other basic supportive treatment.
- Who it may be relevant to
- Registry conditions: Henoch-Schönlein Purpura. Basic parameters: 2 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- sustained abdominal pain relief [Time frame: 3 days after treatment]
Secondary outcome measures (11)
- sustained abdominal pain relief [Time frame: 7 days after treatment]
- other treatment rather than assigned intervention [Time frame: 4 weeks after treatment]
- tolarable food type [Time frame: 2 weeks after treatment]
- the number of days of taking fasting [Time frame: At the time of discharge]
- Drug-related side effects [Time frame: 3 days after treatment]
- hypertension [Time frame: 7 days after treatment]
- infection [Time frame: 4 weeks after treatment]
- ocular hypertension [Time frame: 7 days after treatment]
- steroid-related diabetes [Time frame: 3 days after treatment]
- cost of treatment [Time frame: 4 weeks after treatment]
- The number of days in hospital [Time frame: at the time of discharge]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 3 centers
- Children's Hospital of Fudan University — Shanghai
- Children's Hospital of Shanghai — Shanghai
- Shanghai Children's Medical Centre — Shanghai
Identifiers
NCT: NCT03647852 · chfuHSP 1.0