NCT01010022

Trial of 6% HES130/0.4

Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Fresenius Kabi Japan · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypovolemia
• Hemorrhage

Interventions

Type	Name	Description
DRUG	6% hydroxyethyl starch 130/0.4	Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
DRUG	6% hydroxyethyl starch 70/0.5 (Salinhes®)	Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-07-01
• Completion: 2010-11-01
• First posted: 2009-11-09
• Last updated: 2011-03-10

Locations

7 sites across 1 country: Japan