Multi-center Prospective Randomized Control Trail of High Dose Aspirin in Acute Stage of Kawasaki Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 主要终点
- To assess total hospital day
研究概览
简要总结
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:
- 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).
- 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).
详细描述
All subjects are children who fulfilled the criteria for KD and who are treated with IVIG at each hospital after informed contents are obtained. The patients are initially treated with a single dose of IVIG (2 g/kg) during a 12-hour period.
Principal clinical features of KD that occur in the acute stage within 5 days of the onset of fever will be recorded. After the informed content from the parents, PB samples will be obtained before IVIG treatment (pre-IVIG, KD1), within 3 days after complete initial IVIG treatment (post-IVIG, KD2) as the acute stage samples and then 1 month, 6 month and 12 month followed-up as subacute/convalescent stage samples. CAL was defined as the internal diameter being at least 3 mm of the coronary artery (4 mm if the subject was over the age of 5 years) or the internal diameter of a segment at least 1.5 times as large as that of an adjacent segment by echocardiogram.
High dose aspirin will be given (> 30 mg/kg/day) until the fever subsided at group 1 randomly. After fever subside (<38C, for 48 hours) low-dose aspirin (3-5 mg/kg/day) will be prescribed for all patients until all signs of inflammation resolved in both group 1 and 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(both 1 and 2)
- •All subjects are children who fulfilled the criteria for Kawasaki Disease (American Heart Association criteria).
- •Fever > 5 days, and 4 of the 5 following symptoms
- •Diffuse mucosal inflammation (strawberry tongue, dry and fissured lips)
- •Bilateral non-purulent conjunctivitis,
- •Dysmorphous skin rashes,
- •Indurative angioedema over the hands and feet
- •Cervical lymphadenopathy. (One or more nodule at lease 1.5 cm in diameter)
- •KD patients are treated with IVIG at each hospital after informed contents are obtained.
排除标准
- •Patients whose symptoms did not full fit the Kawasaki Disease criteria.
- •Had an acute fever for < 5 days and >10 days
- •Incomplete collection of each followed-up data (CBC/DC, GOT/GPT, BUN/Cr, Albumin, ESR, C-Reactive Protein, 2D echocardiography)
- •IVIG treatment at other hospital before refers to study centers.
- •Treatment with corticosteroids, other than inhaled forms, in the previous 2 weeks before enrollment;
- •The presence of a disease known to mimic Kawasaki disease.
- •Previous diagnosis of Kawasaki disease
- •Inability to take aspirin
研究组 & 干预措施
with high dose aspirin
KD patients treated with high dose IVIG (2gm/kg) and high dose aspirin (>50mg/kg/day) since diagnosed, then taper to low dose aspirin (3-5mg/kg/day) when fever subside.
干预措施: Aspirin (Drug)
Without high dose aspirin
KD patients treated with high dose IVIG (2gm/kg) without high dose aspirin (>50mg/kg/day) since diagnosed, then low dose aspirin (3-5mg/kg/day) when fever subside.
干预措施: Aspirin (Drug)
结局指标
主要结局
To assess total hospital day
时间窗: 5-10 days
次要结局
- To assess total fever duration(5-10 days)
- To assess how many times of intramenous immunoglobulin (IVIG) treatment(21 days)
- To examine whether coronary artery lesion formation (CAL)(6-8 weeks)