Safety Profile of Hydroxyethyl Starch

October 27, 2011 updated by: B. Braun Melsungen AG

Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42

The study is primarily aimed to collect further data on the safety of the investigational product in a large patient population when used in routine clinical practice in the Asian-Pacific region.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

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

  • China
      • Nanjing, Jiangsu Province, China, 210029
        • Jiangsu Province Hospital
      • Shanghai, China, 200032
        • The Sixth Hospital of Shanghai
      • Shanghai, China, 200080
        • The First Hospital of Shanghai
      • Shanghai, China, 200438
        • Dong Fang Gan Dan Hospital of Shanghai
    • Jiangsu
      • Xuzhou, Jiangsu, China
        • XuZhou Central Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia, 50586
        • Hospital Kuala Lumpur

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

adult patients

Description

Inclusion:

  • patients with ASA risk score ≤ III,
  • non-emergency patients, i.e. elective surgery

Exclusion:

  • contraindications as listed for HES 130/0.42

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
hydroxyethyl starch (HES) 130/0.42
Drug: Venofundin 6% / Tetraspan 6%
Venofundin 6% / Tetraspan 6%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of adverse drug reactions
Time Frame: up to 48 hours
up to 48 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
change in haemodynamics during surgery or intensive care unit stay
Time Frame: up to 48 hours
up to 48 hours

Collaborators and Investigators

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

Sponsor

B. Braun Melsungen AG

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

January 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 25, 2011

Study Record Updates

Last Update Posted (Estimate)

October 28, 2011

Last Update Submitted That Met QC Criteria

October 27, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Other Study ID Numbers

  • HC-O-H-0811

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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