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临床试验/EUCTR2020-005242-41-IT
EUCTR2020-005242-41-IT进行中(未招募)1 期

FIBRINOGEN REPLACEMENT TO PREVENT INTRACRANIAL HAEMORRHAGE IN ISCHEMIC STROKE PATIENTS AFTER THROMBOLYSIS: A PILOT PROBE RANDOMIZED CONTROLLED TRIAL - FibER

AZIENDA USL DI BOLOGNA0 个研究点目标入组 200 人开始时间: 2021年5月20日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - patients with acute ischemic stroke treated with i.v. thrombolysis (rtPA 0,9 mg/Kg, 10% in bolus and 90% in infusion in 60
  • - age >18 years
  • - critical hypofibrinogenemia post-tPA, defined as a decrease of serum fibrinogen level <200 mg/dl and/or a rate decrease
  • >50% than baseline level
  • - written informed consent
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • contraindication to rtPA treatment; patients who present symptomatic ICH during infusion of rt-PA

研究者

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