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
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.
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