Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage
研究概览
简要总结
Terlipressin is an effective and safe treatment for bleeding caused by rupture of oesophageal varices, which are life-threatening complications of liver cirrhosis.
Oesophageal varices are abnormal dilatation of veins occurring in the lower oesophagus, which can develop in patients with cirrhosis. Bleeding caused by rupture of these varices is a life-threatening complication with mortality between 20-50%.
Such bleeding can be treated with drug therapy and/or endoscopic; endoscopic therapy consists of a flexible tube equipped with a camera at the terminal end, allowing for visualizing and treating the oesophageal varices.
In this study, investigators will evaluate the safety and efficacy of terlipressin - Glypressin 1 mg, powder and solvent for solution for injection.
The non-interventional observational study "Follow-up of Glypressin (terlipressin) clinical efficacy in the treatment of bleeding oesophageal varices" aims to demonstrate that administration of Glypressin (terlipressin 1 mg) controls the bleeding in such patients.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients that present an important upper gastrointestinal bleeding, being suspected or diagnosed of liver cirrhosis, with bleeding oesophageal varices visualized endoscopically.
- •(An important upper gastrointestinal bleeding is one requiring at least 2 units/24h of transfused blood).
排除标准
- •Septic shock
- •Patients with recent history of coronary insufficiency
- •Uncontrolled arterial hypertension
- •Chronic respiratory failure
- •Symptomatic arteritis
- •Chronic renal failure
- •Pregnant women
- •Hypersensitivity to terlipressin
- •Patients with body weight below 55 kg
结局指标
主要结局
To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage
时间窗: Up to 6 months
Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis
To evaluate the safety profile of Glypressin: measured by number of patients with adverse events
时间窗: Up to 6 months
次要结局
- To evaluate/monitor the ease of administration in ER(Up to 6 months)