Safety Profile of Hydroxyethyl Starch

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01304433

Enrollment

1000

Registered

2011-02-25

Start date

2009-01-31

Completion date

2011-05-31

Last updated

2011-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Volume Replacement

Brief 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.

Interventions

DRUGVenofundin 6% / Tetraspan 6%

Venofundin 6% / Tetraspan 6%

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Inclusion: * patients with ASA risk score ≤ III, * non-emergency patients, i.e. elective surgery Exclusion: * contraindications as listed for HES 130/0.42

Design outcomes

Primary

Measure	Time frame
number of adverse drug reactions	up to 48 hours

Secondary

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

Countries

China, Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026