Trial of 6% HES130/0.4

Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010022
• Other study ID #: HS-13-02-JP
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2009
• Last updated: March 9, 2011
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2011
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: November 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Hypovolemia

Intervention

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)
• 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)

Locations

Country	Name	City	State
Japan	Kyushu University, Graduate School of Medical Sciences	Fukuoka
Japan	Kobe University Graduate School of Medicine	Kobe
Japan	Okayama University	Okayama
Japan	Osaka University Graduate School of Medicine	Osaka
Japan	Sapporo Medical University, School of Medicine	Sapporo	Hokkaido
Japan	Keio University School of Medicine	Tokyo
Japan	Tokyo Women's Medical University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Kabi Japan

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of colloid solution infused during investigational period (= intra-operatively)		Intra-operatively	No
Secondary	Fluid input		From immediately before induction of anesthesia until 48 hours after end of surgery	No
Secondary	Fluid output		From immediately before induction of anesthesia until 48 hours after end of surgery	No
Secondary	Fluid balance		From immediately before induction of anesthesia until 48 hours after end of surgery	No
Secondary	Hemodynamics		From immediately before induction of anesthesia until 48 hours after end of surgery	No
Secondary	Co-administration of vasoactive drugs		From enrolment until 48 hours after end of surgery	No