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Safety Profile of Hydroxyethyl Starch

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304433
First Posted: February 25, 2011
Last Update Posted: October 28, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
B. Braun Melsungen AG
  Purpose
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

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
1
hydroxyethyl starch (HES) 130/0.42
Drug: Venofundin 6% / Tetraspan 6%
Venofundin 6% / Tetraspan 6%

  Eligibility

Information from the National Library of Medicine

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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
Criteria

Inclusion:

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

Exclusion:

  • contraindications as listed for HES 130/0.42
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304433


Locations
China, Jiangsu
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
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
Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia, 50586
Sponsors and Collaborators
B. Braun Melsungen AG
  More Information

Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT01304433     History of Changes
Other Study ID Numbers: HC-O-H-0811
First Submitted: February 21, 2011
First Posted: February 25, 2011
Last Update Posted: October 28, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes


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