跳至主要内容
临床试验/NCT03887143
NCT03887143已完成不适用

National Retrospective Study Of Recanalization Treatments In Pediatric Arterial Ischemic Stroke (Intra-venous Thrombolysis and/or Endovascular Treatment: Thrombectomy, Intra-arterial Thrombolysis)

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年4月4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
70
试验地点
1
主要终点
Acute management of stroke:

研究概览

简要总结

The purpose of this study is to evaluate recanalization treatments use, safety and efficacy at the acute phase of arterial ischemic stroke in pediatric patients

详细描述

Arterial ischemic stroke outcomes benefited from the implementation of recanalization treatments (IV thrombolysis, endovascular treatments) and adapted management pathways in adult patients. Nevertheless randomized trials did not enroll patients under the age of 18 years old and data concerning these treatments in children are scarce. As it is much less frequent than in adults, recognition of stroke is often delayed in children. Consequently, acute phase trials are difficult to set up and perform. The phase I multicentric international prospective trial TIPS (Thrombolysis in Pediatric Stroke) was prematurely stopped because of poor enrollment. Published retrospective regional (Paris-Ile-de-France region, France) and national (Switzerland) studies addressed the feasibility of such treatments but, because of small samples (less than 20 patients in each study), efficiency and prognostic factors could not be addressed.

Exhaustive retrospective studies in a definite geographic area but with a sufficient number of patients in a limited inclusion period would provide these crucial data and address these questions with good relevance and limited bias.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients under 18 years old
  • Suspected or confirmed cerebral infarction
  • With recanalization treatment in the acute phase : intravenous thrombolysis +/- intra-arterial thrombolysis +/- thrombectomy
  • Patients treated between the January 2015, 1st and the May 2018, 31st
  • Collection of non-opposition from legal representatives

排除标准

  • - Refusal of the patient's legal representative to participate in the study

结局指标

主要结局

Acute management of stroke:

时间窗: 1 day

Median door-to-needle delay (minutes)

次要结局

  • Treatment-emergent adverse events:(7 days)
  • factors potentially associated with clinical outcome: univariate and multivariate analysis, step by step analysis(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验