Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Children's Hospital of Fudan University
150 participants
Sep 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria6
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
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
1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03647852