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Completed

NCT Number: NCT01304433

Safety Profile of Hydroxyethyl Starch

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.

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Key information

Conditions

Plasma Volume Replacement

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuzhou Central Hospital, Xuzhou, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

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

Exclusion:

  • contraindications as listed for HES 130/0.42

Treatment and study plan

Venofundin 6% / Tetraspan 6%

Drug

Venofundin 6% / Tetraspan 6%

Primary outcomes

  1. number of adverse drug reactions

    Time frame: up to 48 hours

Secondary outcomes

  1. change in haemodynamics during surgery or intensive care unit stay

    Time frame: up to 48 hours

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 25, 2011
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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