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临床试验/EUCTR2019-004826-12-NL
EUCTR2019-004826-12-NL进行中(未招募)1 期

Safety and preliminary efficacy of Alkaline Phosphatase in severely burned patients - MAP4B-safety

Association of Dutch Burn Centres0 个研究点目标入组 10 人开始时间: 2021年7月22日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
10

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

  • partial/full thickness acute thermal burns of at least 15% TBSA
  • Admission burn ICU
  • Written informed consent from patient or legal representative
  • 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 8
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 2

排除标准

  • Inclusion in another interventional clinical trial
  • Patients who are pregnant or lactating
  • Patients expected to have fatal disease within 24 hours
  • Patients with chemical burns
  • Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or medical treatment with immunosuppressive effects
  • Patients who have advanced chronic liver disease confirmed by a Child-Pugh C
  • Patients with active haematological malignancy

研究者

发起方
Association of Dutch Burn Centres

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