Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 5
- 主要终点
- Safety Assessment
研究概览
简要总结
The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（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
TNK
Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage.
干预措施: TNK (Drug)
结局指标
主要结局
Safety Assessment
时间窗: From treatment until follow-up date (+/- 30 days)
To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH.
Adverse Event Evaluation
时间窗: From treatment until follow-up date (+/- 30 days)
To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.
次要结局
- Radiological Assessment of the Hematoma Resolution(From treatment until follow-up date (+/- 30 days))
研究者
Gaurav Gupta, MD
Principal Investigator; Professor | Department of Neurosurgery, RWJMS System Co-Director, Cerebrovascular & Endovascular Neurosurgery
Rutgers, The State University of New Jersey