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临床试验/NCT01359202
NCT01359202已完成2 期

"Spot Sign" Selection of Intracerebral Hemorrhage to Guide Hemostatic Therapy: SPOTLIGHT

Dr. David Gladstone21 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2011年5月最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Niastase RT

Active Comparator

Niastase RT 80ug/kg IV bolus

干预措施: rfVIIa (Biological)

Placebo

Placebo Comparator

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

发起方
Dr. David Gladstone
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. David Gladstone

Principal Investigator - Sponsor

Sunnybrook Health Sciences Centre

研究点 (21)

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