跳至主要内容
临床试验/NCT03634748
NCT03634748已完成不适用

Thrombolysis in stRoke With Unknown onSet Based on Non-contrasT CT (TRUST CT). An International, Multicenter, Registry-based Study

University Hospital Tuebingen5 个研究点 分布在 4 个国家目标入组 117 人开始时间: 2017年9月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Sven Poli

Deputy Director

University Hospital Tuebingen

研究点 (5)

Loading locations...

相似试验