Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease
Status:
Unknown status
Trial end date:
2017-04-01
Target enrollment:
Participant gender:
Summary
Kawasaki disease (KD) is an acute multi-system vasculitis syndrome of unknown etiology
occurring mostly in infants and children younger than 5 years of age. In developed countries,
it is the leading cause of acquired heart disease in children. However, KD remains a
mysterious disease.
Single high dose intravenous immunoglobulin (IVIG, 2gm/kg) and aspirin are standard treatment
for KD. Aspirin have been prescribed in treatment of KD for decade even earlier than usage of
IVIG. High dose aspirin mainly act as anti-inflammation, while low dose aspirin as
anti-platelet. IVIG may play most of the role of anti-inflammation in acute stage of KD.
Hsieh et al. reported that KD without high dose aspirin had the same treatment response after
IVIG. Therefore it is still unclear about the necessarily of high dose aspirin in acute stage
of KD.
This study was conduct to investigate the role of high dose aspirin in acute stage of KD via
a multi-center randomized control trail, and we plan to achieve the followings till year
2017:
1. Enroll 300 KD patients from multiple medical centers . Randomize group patients as group
1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low
dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute
febrile stage, only use low dose aspirin (N=150).
2. Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT,
BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate
(followed at least 1 year).