Trial of 6% HES130/0.4

Examination of Safety and Efficacy of 6% Hydroxyethyl Starch 130/0.4 vs. 6% Hydroxyethyl Starch 70/0.5 in Patients Undergoing Orthopedic Surgery - a Double-blind, Parallel Group, Comparative, Multi-centre Phase III Study

The study shall evaluate the efficacy and safety of two different hydroxyethyl starch solutions (artificial colloids 6% HES130/0.4 and 6% HES70/0.5, Salinhes®) for intra-operative therapy of hypovolemia and maintenance of circulating blood volume in patients undergoing orthopedic surgery. The primary efficacy endpoint will be the required volume of colloid solution infused from start until end of surgery. It is the aim of the clinical trial to demonstrate that comparable volumes of colloid solution are used between treatment groups.

Inclusion Criteria:

• Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
• Patients with a body weight (BW) ≥ 50 kg

Exclusion Criteria:

• Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
• ASA classification ≥ IV
• Renal disease (serum creatinine ≥ 2mg/dL)
• Known bleeding disorders
• Congestive heart failure
• Fluid overload
• Intracranial bleeding
• Severe hypernatremia
• Severe hyperchloremia