drugset
drugset / Trial / NCT00860405

Voluven® in Paediatric Patients

NCT00860405 ↗

Phase 4 Completed 61 enrolled Fresenius Kabi
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

Timeline

Start
2009-03
Primary completion
2010-08
Completion
2010-12

Outcome

Met primary endpoint

registry Ratio of LS-means 0.98 (95% CI 0.84 to 1.16) NCT00860405 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Human Serum Albumin Protein / enzyme biologic — —
Subject Volulyte Other / unclassified — —

Indications

cardiac valvular defect