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Safety Profile of Hydroxyethyl Starch

This study has been completed.
Information provided by (Responsible Party):
B. Braun Melsungen AG Identifier:
First received: February 21, 2011
Last updated: October 27, 2011
Last verified: October 2011
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.

Condition Intervention
Plasma Volume Replacement
Drug: Venofundin 6% / Tetraspan 6%

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation on the Safety Profile of Hydroxyethyl Starch (HES) 130/0.42

Resource links provided by NLM:

Further study details as provided by B. Braun Melsungen AG:

Primary Outcome Measures:
  • number of adverse drug reactions [ Time Frame: up to 48 hours ]

Secondary Outcome Measures:
  • change in haemodynamics during surgery or intensive care unit stay [ Time Frame: up to 48 hours ]

Estimated Enrollment: 1000
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
hydroxyethyl starch (HES) 130/0.42
Drug: Venofundin 6% / Tetraspan 6%
Venofundin 6% / Tetraspan 6%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult patients


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


  • contraindications as listed for HES 130/0.42
  Contacts and Locations
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Please refer to this study by its identifier: NCT01304433

China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Jiangsu Province Hospital
Nanjing, Jiangsu Province, China, 210029
The Sixth Hospital of Shanghai
Shanghai, China, 200032
The First Hospital of Shanghai
Shanghai, China, 200080
Dong Fang Gan Dan Hospital of Shanghai
Shanghai, China, 200438
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Sponsors and Collaborators
B. Braun Melsungen AG
  More Information

Responsible Party: B. Braun Melsungen AG Identifier: NCT01304433     History of Changes
Other Study ID Numbers: HC-O-H-0811
Study First Received: February 21, 2011
Last Updated: October 27, 2011

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes processed this record on May 25, 2017