Safety Profile of Hydroxyethyl Starch

Plasma Volume Replacement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304433
• Other study ID #: HC-O-H-0811
• Status: Completed
• Phase: N/A
• First received: February 21, 2011
• Last updated: October 27, 2011
• Start date: January 2009
• Est. completion date: May 2011

Study information

• Verified date: October 2011
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• patients with ASA risk score = III,

• non-emergency patients, i.e. elective surgery

Exclusion:

• contraindications as listed for HES 130/0.42

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Plasma Volume Replacement

Intervention

Drug:
• Venofundin 6% / Tetraspan 6%
Venofundin 6% / Tetraspan 6%

Locations

Country	Name	City	State
China	Jiangsu Province Hospital	Nanjing, Jiangsu Province
China	Dong Fang Gan Dan Hospital of Shanghai	Shanghai
China	The First Hospital of Shanghai	Shanghai
China	The Sixth Hospital of Shanghai	Shanghai
China	Xuzhou Central Hospital	Xuzhou	Jiangsu
Malaysia	Hospital Kuala Lumpur	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Countries where clinical trial is conducted

China,  Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of adverse drug reactions		up to 48 hours	Yes
Secondary	change in haemodynamics during surgery or intensive care unit stay		up to 48 hours	No