Trial | NCT01010022  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    hydroxyethyl starch ...

  • Study Participants

    64
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.
Study Started
Nov 30
2009
Primary Completion
Jul 31
2010
Study Completion
Nov 30
2010
Last Update
Mar 10
2011
Estimate

Drug 6% hydroxyethyl starch 130/0.4

Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)

Drug 6% hydroxyethyl starch 70/0.5 (Salinhes®)

Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

1 Experimental

Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)

2 Active Comparator

Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)

Criteria 

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
No Results Posted