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Trial of 6% HES130/0.4

This study has been completed.
Sponsor:
Information provided by:
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT01010022
First received: November 6, 2009
Last updated: March 9, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypovolemia
Hemorrhage
 Drug: 6% hydroxyethyl starch 130/0.4
Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®)
 Phase 3

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

Resource links provided by NLM:

Drug Information available for: Hetastarch
U.S. FDA Resources

Further study details as provided by Fresenius Kabi:

Primary Outcome Measures:
  • Volume of colloid solution infused during investigational period (= intra-operatively) [ Time Frame: Intra-operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fluid input [ Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: No ]
  • Fluid output [ Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: No ]
  • Fluid balance [ Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: No ]
  • Hemodynamics [ Time Frame: From immediately before induction of anesthesia until 48 hours after end of surgery ] [ Designated as safety issue: No ]
  • Co-administration of vasoactive drugs [ Time Frame: From enrolment until 48 hours after end of surgery ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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 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)
Active Comparator: 2
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) 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)

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010022

Locations
Japan
Sapporo Medical University, School of Medicine
Sapporo, Hokkaido, Japan, 060-8543
Kyushu University, Graduate School of Medical Sciences
Fukuoka, Japan, 812-8582
Kobe University Graduate School of Medicine
Kobe, Japan, 650-0017
Okayama University
Okayama, Japan, 700-8558
Osaka University Graduate School of Medicine
Osaka, Japan, 565-0871
Tokyo Women's Medical University
Tokyo, Japan, 162-8666
Keio University School of Medicine
Tokyo, Japan, 160-8582
Sponsors and Collaborators
Fresenius Kabi Japan
Investigators
Study Chair: Akiyoshi Namiki, MD, PhD Emeritus Professor, Sapporo Medical University
  More Information

No publications provided

Responsible Party: Tsuneo Tsubaki, PhD, Pharm.D., Fresenius Kabi Japan K.K.
ClinicalTrials.gov Identifier: NCT01010022     History of Changes
Other Study ID Numbers: HS-13-02-JP
Study First Received: November 6, 2009
Last Updated: March 9, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Fresenius Kabi:
hypovolemia
surgical blood loss
orthopedic procedures
Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Hypovolemia
Pathologic Processes
Hetastarch
Plasma Substitutes
 Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013