Trial of 6% HES130/0.4
Primary Purpose
Hypovolemia, Hemorrhage
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
6% hydroxyethyl starch 130/0.4
6% hydroxyethyl starch 70/0.5 (Salinhes®)
Sponsored by
About this trial
This is an interventional treatment trial for Hypovolemia focused on measuring hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
Eligibility 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
Sites / Locations
- Sapporo Medical University, School of Medicine
- Kyushu University, Graduate School of Medical Sciences
- Kobe University Graduate School of Medicine
- Okayama University
- Osaka University Graduate School of Medicine
- Keio University School of Medicine
- Tokyo Women's Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
Outcomes
Primary Outcome Measures
Volume of colloid solution infused during investigational period (= intra-operatively)
Secondary Outcome Measures
Fluid input
Fluid output
Fluid balance
Hemodynamics
Co-administration of vasoactive drugs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010022
Brief Title
Trial of 6% HES130/0.4
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fresenius Kabi Japan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia, Hemorrhage
Keywords
hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
Intervention Type
Drug
Intervention Name(s)
6% hydroxyethyl starch 130/0.4
Intervention Description
Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery)
Intervention Type
Drug
Intervention Name(s)
6% hydroxyethyl starch 70/0.5 (Salinhes®)
Intervention Description
Up to 1000mL 6% hydroxyethyl starch 70/0.5 (Salinhes®) solution i.v., intra-operatively (from start of surgery until end of surgery)
Primary Outcome Measure Information:
Title
Volume of colloid solution infused during investigational period (= intra-operatively)
Time Frame
Intra-operatively
Secondary Outcome Measure Information:
Title
Fluid input
Time Frame
From immediately before induction of anesthesia until 48 hours after end of surgery
Title
Fluid output
Time Frame
From immediately before induction of anesthesia until 48 hours after end of surgery
Title
Fluid balance
Time Frame
From immediately before induction of anesthesia until 48 hours after end of surgery
Title
Hemodynamics
Time Frame
From immediately before induction of anesthesia until 48 hours after end of surgery
Title
Co-administration of vasoactive drugs
Time Frame
From enrolment until 48 hours after end of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Akiyoshi Namiki, MD, PhD
Organizational Affiliation
Emeritus Professor, Sapporo Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Sapporo Medical University, School of Medicine
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Kyushu University, Graduate School of Medical Sciences
City
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kobe University Graduate School of Medicine
City
Kobe
ZIP/Postal Code
650-0017
Country
Japan
Facility Name
Okayama University
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Osaka University Graduate School of Medicine
City
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Keio University School of Medicine
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Tokyo Women's Medical University
City
Tokyo
ZIP/Postal Code
162-8666
Country
Japan
12. IPD Sharing Statement
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Trial of 6% HES130/0.4
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