"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 21
- 主要终点
- ICH size
研究概览
简要总结
This clinical trial will enroll 110 patients from approximately 15 Canadian stroke centres. Patients coming to the emergency department with bleeding in the brain not due to trauma or other known causes who can be treated within 6 hours of onset will undergo CT angiography using standard CT scanners ("CAT scan"). Those with a "spot sign", a type of marker on the CT scan that shows the brain is still bleeding, will be randomly assigned to a single injection of "factor 7"(a blood clotting drug used in hemophilia) or placebo (inactive saline); patients without a spot sign will not be treated. The researchers will look at how much bleeding happens after the treatments are administered, as well as clinical outcomes such as death and disability. The researchers think that factor 7 will cause the bleeding to stop faster and possibly decrease death and disability.
详细描述
This phase II double blind RCT will enroll 110 patients from approximately 15 Canadian stroke centres. Acute ICH patients who can be treated within 6 hours of onset will undergo CT angiography using standard CT procedures. Those with a spot sign will be randomly assigned in a 1:1 ratio to a single injection of rFVIIa 80 µg/kg or placebo; patients without a spot sign will not be treated. The primary endpoint is ICH expansion within 24 hours.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Niastase RT
Niastase RT 80ug/kg IV bolus
干预措施: rfVIIa (Biological)
Placebo
saline IV bolus
干预措施: Standard saline solution (Other)
结局指标
主要结局
ICH size
时间窗: 24 hours
Difference between groups in ICH size on CT scan at 24 hours post-dose, adjusted for baseline ICH size
次要结局
- DVT(4 days)
- Thromboembolic events(4 days)
- Mortality(90 days)
- Unstable angina(4 days)
- Troponin increase(4 days)
- Feasibility(0)
- Waiver of consent process evaluation/effectiveness(4,90 days)
- Acute blood pressure control(1hr)
- Cognition(90 days, 1 year)
- Pulmonary embolism(30 days)
- Disability(90 d, 1 year)
研究者
Dr. David Gladstone
Principal Investigator - Sponsor
Sunnybrook Health Sciences Centre
