Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
ConditionHenoch-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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Methylprednisolone
Drug1.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
IVIG
Drug1\. 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
other basic supportive treatment
Drug1. Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day 2. Low molecular weight heparin calcium 50IU/kg.d
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Methylprednisolone groupExperimental treatment 2 interventions
Group B: IVIG groupActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
sustained abdominal pain relief
no abdominal pain complaint and no abdominal tenderness
Time frame
3 days after treatmentSecondary outcomes
1
sustained abdominal pain relief
3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment
Time frame
7 days after treatment2
other treatment rather than assigned intervention
other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
Time frame
4 weeks after treatment3
tolarable food type
what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
Time frame
2 weeks after treatment4
the number of days of taking fasting
the number of days of taking fasting will be counted at the time of discharge
Time frame
At the time of dischargeSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital of Fudan University
Lead sponsor
Shanghai Children's Hospital
Collaborator
Shanghai Children's Medical Center
Collaborator
Source ClinicalTrials.gov