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临床试验/EUCTR2010-021186-70-GB
EUCTR2010-021186-70-GB进行中(未招募)不适用

Keratinocyte growth factor in Acute lung injury to REduce pulmonary dysfunction – a randomised placebo controlled trial (KARE) - Keratinocyte Growth Factor in Acute Lung Injury

Belfast Health and Social Care Trust0 个研究点目标入组 60 人开始时间: 2010年10月8日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60

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

  • ALI as defined by acute onset of:
  • a.hypoxic respiratory failure (PaO2/FiO2 = 40 kPa)
  • b.bilateral infiltrates on chest X-ray consistent with pulmonary oedema.
  • c.no clinical evidence of left atrial hypertension or if measured, a
  • pulmonary arterial occlusion pressure (PAOP) less than or equal to 18 mmHg.
  • d.requirement for invasive positive pressure mechanical ventilation via an
  • endotracheal tube or tracheostomy
  • All ALI criteria (a-d above) must occur within the same 24-hour period. The onset of ALI is when the last ALI criterion is met. Patients must be enrolled within 72 hours of ALI onset.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 0
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 0

排除标准

  • 1.Age < 18 years
  • 2.More than 72 hours from the onset of ALI
  • 3.Pregnancy
  • 4.Participation in a clinical trial of an investigational medicinal product
  • within 30 days
  • 5.Consent declined
  • 6.Current treatment with KGF
  • 7.Known hypersensitivity to palifermin or Escherichia coli derived proteins
  • 8.Previous adverse reaction to palifermin.
  • 9.History of active malignancy excludig haematological malignancies.
  • 10.Chronic liver disease with Child-Pugh score greater than 12.

研究者

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