Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 5
- 主要终点
- sICH
研究概览
简要总结
Multicentric, observational, registry-based study of 0.9 mg/kg i.v. thrombolysis in wake-up stroke or stroke with unknown onset based on non-contrast CT appearance only
详细描述
Thrombolysis in wake-up stroke (WUS) or stroke with unknown onset (SUO) has been recently proven to be safe and effective using magnetic resonance imaging (MRI). However, in most of the thrombolyzing hospitals worldwide MR imaging is not available. We hypothesize that pragmatic non-contrast CT (NCCT)-based WUS/SUO thrombolysis may be feasible and safe.
Methods: TRUST-CT is an international multicenter registry-based study. WUS/SUO patients undergoing NCCT-based thrombolysis with NIHSS ≥ 4 and initial ASPECTS ≥ 7 are included and compared to propensity score matched non-thrombolyzed WUS/SUO controls. Primary endpoint is symptomatic intracranial hemorrhage (ICH); secondary endpoints include 24-hour NIHSS change of ≥ 4 and modified Rankin Score (mRS) at 90 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
结局指标
主要结局
sICH
时间窗: 72hours
symptomatic ICH according to ECASS3
次要结局
- mRS 90 days(90 days)
研究者
Dr. Sven Poli
Deputy Director
University Hospital Tuebingen
