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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-08-31

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.

Detailed Description

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Conditions

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Gastrointestinal Bleeding Oesophageal Varices

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Glypressin (terlipressin)

Study drug (without placebo)

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Support

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Emergency County Hospital - Surgery Clinic No.1

Târgu Mureş, Mureș County, Romania

Site Status

Countries

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Romania

Other Identifiers

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FE999908 CS04

Identifier Type: -

Identifier Source: org_study_id