EUCTR2007-003635-23-GB进行中（未招募）1 期
A PRELIMINARY EVALUATION OF THE SAFETY PROFILE OF TWENTY-FOUR HOUR INFUSION OF HUMAN RECOMBINANT ACTIVATED PROTEIN C (XIGRIS) EARLY IN SEVERE ACUTE PANCREATITIS. - XIG-AP 1
Central Manchester and Manchester Children's Hospitals NHS Trust0 个研究点目标入组 30 人开始时间: 2009年9月14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）
- 发起方
- 入组人数
- 30
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
入选标准
- •1.Acute pancreatitis – defined as acute abdominal pain with a threefold
- •elevation of serum amylase or a twofold elevation of serum lipase.
- •2.Severe disease – defined as an APACHE II score of = 15 on admission to hospital together with a logistic organ dysfunction score of = 2 within the first 24 hours of admission to hospital.
- •3.Early disease – defined as being within 72 hours of onset of severe pain.
- •4.No clinical evidence of haemorrhage
- •5.Patients with no prior history of bleeding duodenal ulcer, haemorrhagic stroke or other haemorrhagic diathesis.
- •6.Patients not taking warfarin or other anticoagulant medication.
- •7.Patients without evidence of end-stage renal disease
- •8.Patients who are not pregnant or lactating.
- •9.Over 18 years of age.
- •10.No surgery or endoscopic retrograde cholangiopancreatography (ERCP) within the previous 30 days.
- •11.Patients able to give informed consent (or complying with current United Kingdom criteria for consent in critical care unit trials).
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Inability to give consent.
- •2.Non-severe acute pancreatitis – defined as an APACHE II score of < 15 on admission to hospital.
- •3.Later presentation: in excess of 72 hours after onset of severe pain.
- •4.Clinical evidence of haemorrhage.
- •5.Patients with a prior history of bleeding duodenal ulcer, haemorrhagic stroke or other haemorrhagic diathesis.
- •6.Patients taking warfarin or other anticoagulant medication. Thrombocytopenia, coagulopathy.
- •7.Patients with evidence of end-stage renal disease. Patients with liver disease.
- •8.Under 18 years of age.
- •9.Surgery or ERCP within the previous 30 days.
- •10.Patients who may be pregnant or lactating.
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