Safety Profile of Hydroxyethyl Starch

B. Braun

Status: Completed

Conditions: Plasma Volume Replacement

Treatments: Drug: Venofundin 6% / Tetraspan 6%

Study type: Observational

Funder types: Industry

Identifiers

NCT01304433

HC-O-H-0811

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion:

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

Exclusion:

• contraindications as listed for HES 130/0.42

Trial design

1,000 participants in 1 patient group

1

Description:

hydroxyethyl starch (HES) 130/0.42

Treatment:

Drug: Venofundin 6% / Tetraspan 6%