Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

Study Overview
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Brief Summary
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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.

Official Title
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Follow-up of Glypressin (Terlipressin) Clinical Efficacy in the Treatment of Bleeding Oesophageal Varices

Conditions
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Gastrointestinal Bleeding, Oesophageal Varices

Intervention / Treatment
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* Other: Glypressin (terlipressin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Glypressin (terlipressin)|Study drug (without placebo)|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical efficacy of Glypressin: measured by rapid control of heamorrhage; reduced mortality post-haemorrhage | Vital signs (blood pressure, heart rate, and body temperature) and routine safety lab analysis | Up to 6 months | 
| To evaluate the safety profile of Glypressin: measured by number of patients with adverse events |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate/monitor the ease of administration in ER | Easiness of use in ER (easy to reconstitute, easy to administer, flexible dosage) | Up to 6 months |