Trial of 6% HES130/0.4

March 9, 2011 updated by: Fresenius Kabi Japan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University, Graduate School of Medical Sciences
      • Kobe, Japan, 650-0017
        • Kobe University Graduate School of Medicine
      • Okayama, Japan, 700-8558
        • Okayama University
      • Osaka, Japan, 565-0871
        • Osaka University Graduate School of Medicine
      • Tokyo, Japan, 160-8582
        • Keio University School of Medicine
      • Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University, School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
  • Patients with a body weight (BW) ≥ 50 kg

Exclusion Criteria:

  • Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
  • ASA classification ≥ IV
  • Renal disease (serum creatinine ≥ 2mg/dL)
  • Known bleeding disorders
  • Congestive heart failure
  • Fluid overload
  • Intracranial bleeding
  • Severe hypernatremia
  • Severe hyperchloremia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
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 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)
ACTIVE_COMPARATOR: 2
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Volume of colloid solution infused during investigational period (= intra-operatively)
Time Frame: Intra-operatively
Intra-operatively

Secondary Outcome Measures

Outcome Measure
Time Frame
Fluid input
Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery
From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid output
Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery
From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid balance
Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery
From immediately before induction of anesthesia until 48 hours after end of surgery
Hemodynamics
Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery
From immediately before induction of anesthesia until 48 hours after end of surgery
Co-administration of vasoactive drugs
Time Frame: From enrolment until 48 hours after end of surgery
From enrolment until 48 hours after end of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fresenius Kabi Japan

Investigators

  • Study Chair: Akiyoshi Namiki, MD, PhD, Emeritus Professor, Sapporo Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

July 1, 2010

Study Completion (ACTUAL)

November 1, 2010

Study Registration Dates

First Submitted

November 6, 2009

First Submitted That Met QC Criteria

November 6, 2009

First Posted (ESTIMATE)

November 9, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 10, 2011

Last Update Submitted That Met QC Criteria

March 9, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-13-02-JP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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