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临床试验/EUCTR2020-005731-67-NL
EUCTR2020-005731-67-NL进行中(未招募)1 期

Complement Inhibition: Attacking the Overshooting Inflammation @fter Subarachnoid Hemorrhage - A phase II trial on the safety and efficacy of C1esterase inhibitor for the acute management of subarachnoid hemorrhage - CIAO@SAH

Haaglanden Medisch Centrum0 个研究点目标入组 128 人开始时间: 2021年3月10日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
128

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

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • -Confirmed diagnosis of aneurysmal subarachnoid hemorrhage on CT-scan or lumbar puncture (in the presence of a negative CT-scan);
  • -Age = 18 years on admission;
  • -WFNS grade 1-5
  • 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 60
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 68

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • -Subarachnoid hemorrhage deemed most likely to ‘peri mesencephalic’ origin after consideration of history, clinical examination and radiological findings (including angiographic imaging);
  • -Subarachnoid hemorrhage deemed most likely of post-traumatic origin after consideration of history, clinical examination and radiological findings (including angiographic imaging);
  • -Participation in another clinical therapeutic study;
  • -Patients with a known hereditary complement deficiency (including hereditary angioedema);
  • -Patients with a history of sensibility to blood products or C1-inhibitor;
  • -Patients with a history of thrombosis;
  • -Pregnant woman

研究者

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