Skip to main content
OpenTrials
Recruiting

NCT Number: NCT03647852

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Henoch-Schönlein Purpura Blood Coagulation Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

2 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital of Fudan University, Shanghai, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methylprednisolone

Drug

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

IVIG

Drug
  • 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

Drug
  • Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day
  • Low molecular weight heparin calcium 50IU/kg.d

Primary outcomes

  1. sustained abdominal pain relief

    Time frame: 3 days after treatment

    no abdominal pain complaint and no abdominal tenderness

Secondary outcomes

  1. sustained abdominal pain relief

    Time frame: 7 days after treatment

    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

  2. other treatment rather than assigned intervention

    Time frame: 4 weeks after treatment

    other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed

  3. tolarable food type

    Time frame: 2 weeks after treatment

    what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )

  4. the number of days of taking fasting

    Time frame: At the time of discharge

    the number of days of taking fasting will be counted at the time of discharge

  5. Drug-related side effects

    Time frame: 3 days after treatment

    Side effects associated with methylprednisolone and IVIG will be recorded

  6. hypertension

    Time frame: 7 days after treatment

    systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.

  7. infection

    Time frame: 4 weeks after treatment

    different infection types should be specified

  8. ocular hypertension

    Time frame: 7 days after treatment

    1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg

  9. steroid-related diabetes

    Time frame: 3 days after treatment

    • with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l

  10. cost of treatment

    Time frame: 4 weeks after treatment

    cost of treatment will be obtained from discharge fee list

  11. The number of days in hospital

    Time frame: at the time of discharge

    The number of days in hospital will be counted at the time of discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Li Sun, MD

CONTACT

[email protected]

+8618017590930

Sponsors and collaborators

Lead sponsor

Children's Hospital of Fudan University

Other

Collaborators

  • Shanghai Children's Hospital
  • Shanghai Children's Medical Center

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Aug 27, 2018
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.