drugset / Trial / NCT01010022

Trial of 6% HES130/0.4

NCT01010022

Phase 3 Completed 64 enrolled Fresenius Kabi Japan
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.

Timeline

Start
2009-11
Primary completion
2010-07
Completion
2010-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Volulyte Other / unclassified 1000 ml Intravenous
Comparator hydroxyethyl starch 70/0.5 Unknown 1000 ml Intravenous

Indications