NCT01528943已完成1 期
The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in endothelial biomarkers
研究概览
简要总结
The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Men and women above 18 years old
- •Undergoing Whipple surgery or liver resection
- •Able and willing to give informed consent
排除标准
- •Allergy towards the study medication
- •In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists
- •Autoimmune disease
- •Intracranial bleeding within the last 6 months
- •Acute coronary syndrome or myocardial infarction within the last 6 months
- •Congestive heart disease
- •Pregnant or breastfeeding
- •Participating in another clinical study within the last 30 days
- •Liver cirrhosis
- •Need for renal replacement therapy
研究组 & 干预措施
Prostacyclin
Experimental
Treatment with prostacyclin
干预措施: Prostacycline (Drug)
Isotonic saline
Placebo Comparator
Treatment with isotonic saline
干预措施: Isotonic saline (Drug)
结局指标
主要结局
Change in endothelial biomarkers
时间窗: Baseline to 6 hours postoperatively
次要结局
- Functional haemostasis evaluated by thrombelastography(Baseline to 6 hours postoperatively)
研究者
Pär Johansson
Medical Director
Rigshospitalet, Denmark
研究点 (1)
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