Clinical trial NCT03647852: Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Official title: Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Henoch-Schönlein Purpura
Keywords: severe gastrointestinal involvement
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Children's Hospital
name: Shanghai Children's Medical Center
First posted: 2018-08-27
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

1. both genders
2. age between 2-16 years old
3. IgA vasculitis with gastrointestinal involvement
4. course of disease less than 2 months
5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）

Exclusion Criteria:

1. patients with severe sepsis
2. patients with central nervous system infection,
3. patients with severe pneumonia
4. patients with chronic infection (such as EBV, CMV, Tuberculosis)
5. patients complicated by CKD who need renal replacement therapy
6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

Primary outcomes:
measure: sustained abdominal pain relief
timeFrame: 3 days after treatment
Secondary outcomes:
measure: sustained abdominal pain relief
timeFrame: 7 days after treatment
measure: other treatment rather than assigned intervention
timeFrame: 4 weeks after treatment
measure: tolarable food type
timeFrame: 2 weeks after treatment
measure: the number of days of taking fasting
timeFrame: At the time of discharge
measure: Drug-related side effects
timeFrame: 3 days after treatment
measure: hypertension
timeFrame: 7 days after treatment
measure: infection
timeFrame: 4 weeks after treatment
measure: ocular hypertension
timeFrame: 7 days after treatment
measure: steroid-related diabetes
timeFrame: 3 days after treatment
measure: cost of treatment
timeFrame: 4 weeks after treatment
measure: The number of days in hospital
timeFrame: at the time of discharge
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
city: Shanghai
country: China
facility: Children's Hospital of Shanghai
city: Shanghai
country: China
facility: Shanghai Children's Medical Centre
Study officials:
affiliation: Children's Hospital of Fudan University
name: Li Sun, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Children's Hospital
name: Wenyan Huang, MD
role: PRINCIPAL_INVESTIGATOR
References: