Multi-center, Prospective Randomized, Comparative Open With Blinded Endpoints (PROBE) Trial to Assess the Safety and Effectiveness of Administration of Celecoxib in Patients With Intracerebral Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of volume of perihematomal edema as assessed by brain CT
研究概览
简要总结
Primary:
Change of volume of perihematomal edema as assessed by brain CT.
Secondary:
The change of ICH volume between the initial and the follow-up CT scans The neurological status at 90 day using E-GOS and mRS. The cumulative incidence of major and minor adverse events that occurred during and after hospitalization until the end of the study
详细描述
-
INCLUSION/EXCLUSION CRITERIA
-
Inclusion Criteria
- Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
- Supratentorial location of hemorrhage
- Older than 17 yrs
- Informed consent before study
- Exclusion Criteria
- Planned surgical evacuation of hematoma within 24hrs
- Secondary ICH such as trauma or aneurysmal rupture
- Taking anticoagulation previously
- Pregnancy,known allergy to celecoxib, severe liver or kidney disease, or poor performance state were excluded
- Other physical condition, making the patient difficult to participate in this study (decided by the neurologist or the physician).
- OTHER THERAPY
-No limitation of other medications except NSAIDs, anticoagulation and antiplatelet agent because of aggravating the symptoms 3. STUDY DESIGN Multicenter, prospective randomized, comparative open with blinded endpoints (PROBE) trial to assess the safety and effectiveness of administration of celecoxib for 14 days in patients with intracerebral hemorrhage
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spontaneous intracerebral hemorrhage was documented by CT scanning within 24 hours of the onset of symptoms
- •Supratentorial location of hemorrhage
- •Older than 17 yrs
排除标准
- •Planned surgical evacuation of hematoma within 24hrs
- •Secondary ICH due to trauma or aneurismal rupture or etc
- •Taking antithrombotics or other NSAIDs previously
- •Other physical condition, making the patient difficult to participate the study (decided by the neurologist or the physician).
研究组 & 干预措施
2
In the intervention group, patients will take celecoxib.
干预措施: celecoxib medication (Drug)
结局指标
主要结局
Change of volume of perihematomal edema as assessed by brain CT
时间窗: at 1st day of admission and repeated at 7th±1 day
Brain CT scanning for measurement of volumes of ICH and perihematomal edema was performed at 1st day of admission and repeated at 7th±1 day. Considering some possible errors in measurement of edema volume, at follow-up CT scan, the decrease more than 20% from the initial edema volume was coded as "decreased" edema volume; the increase more than 20% was coded as "increased"; the change between -20% and 20% was coded as "unchanged".
次要结局
- Change of ICH volume between the initial and the follow-up CT scans(Day1, Day 7)
- Major and minor adverse events(anytime for 3 months)
- The neurological status at 90 day using E-GOS and mRS(90 days after onset.)