drugset / Trial / NCT00161915

Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices

NCT00161915

Phase 3 Completed Baxter Healthcare Corporation
RandomizedParallel-groupSingle-blindTreatment

Summary

The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of the first seven days without clinically significant bleeding.

Timeline

Start
2000-12
Primary completion
Completion
2004-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Fibrinogen Concentrate Human Protein / enzyme biologic Other

Indications