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Trial of 6% HES130/0.4

NCT01010022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2011-03-10

No results posted yet for this study

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

Interventions

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)

Sponsors & Collaborators

  • Fresenius Kabi Japan

    lead INDUSTRY

Principal Investigators

  • Akiyoshi Namiki, MD, PhD · Emeritus Professor, Sapporo Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-07-31
Completion
2010-11-30

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01010022 on ClinicalTrials.gov