APCAP - Activated Protein C in Severe Acute Pancreatitis: A Double-blind Randomized Human Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5.
研究概览
简要总结
Activated protein C (APC)has been shown to reduce mortality in severe sepsis(Bernard et al. 2001b). The clinical picture of severe acute pancreatitis (AP) is similar to that of sepsis. The investigators conducted a randomised double-blinded placebo-controlled pilot study in AP patients (16+16) with the same dose of APC that has been proven to be efficacious and safe in septic patients.
The aim of the study is to investigate whether the APC replacement therapy diminishes the occurrence and severity of organ dysfunction in patients with severe AP. The effect of APC on inflammatory and hemostatic parameters is also assessed.
详细描述
The study started in 2003 and was finished in 2007. The study was registered in The Helsinki University Central Hospital study register in 2003.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to hospital within 72 h of the onset of pain.
- •Plasma amylase concentration more than three times the upper limit of the normal range and/or CT findings compatible with AP.
- •Organ failure and <48h of the onset of the first organ failure
排除标准
- •HIV / B- or C hepatitis infection
- •Pregnancy or breast feeding
- •Active bleeding
- •Increased risk of bleeding (thrombocytes <30x10E9/L or INR>3.0
- •Gastrointestinal bleeding within 6 weeks or intracranial stroke within 3 months before the study
- •Intravenous contrast extravasation or other signs (fresh hematoma) suggesting active hemorrhage within the pancreas or in the peripancreatic area on admission CT scan
- •Use of antithrombin III within 12 h
- •Use of acetylsalicylic acid or glycoprotein IIB/IA antagonist within 7 days / Thrombolytic therapy within 3 days
- •Surgery requiring general or spinal anaesthesia within 12 h
- •Previous pancreatic surgery
- •Application of an epidural catheter within 48 h
研究组 & 干预措施
Activated protein C
干预措施: Activated protein C (Drug)
结局指标
主要结局
The primary safety endpoint was the number of bleedings, and the primary efficacy endpoint was the change in SOFA between the start of the drug (day 0) and day 5.
时间窗: 0-60 days
次要结局
- Organ failure free days alive(0-60 days)