drugset / Trial / NCT00308126

Study to Evaluate the Effect of Hydroxyethyl Starch (HES) in Complications of Patients After Abdominal Surgery

NCT00308126

Phase 4 Completed 624 enrolled Fresenius Kabi
RandomizedParallel-groupOpen-labelTreatment

Summary

Purpose: To compare the incidence of post-surgery complications and evaluate relevant parameters within 28 days after an operation in HES (130/0.4) and albumin treated groups Study Design: Open-label, active controlled, parallel group, randomized, multi-center study. Per protocol, 624 patients required in 6 study centers. Hypothesis: No difference in rate of postoperative (post-op) complications between HES and albumin groups

Timeline

Start
2005-06
Primary completion
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject hydroxyethyl starch Other / unclassified

Indications

No indication recorded.