NCT01010022

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 9, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 10, 2011

Status Verified

March 1, 2011

Enrollment Period

8 months

First QC Date

November 6, 2009

Last Update Submit

March 9, 2011

Conditions

HypovolemiaHemorrhage

Keywords

hypovolemiasurgical blood lossorthopedic proceduresTreatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Volume of colloid solution infused during investigational period (= intra-operatively)

    Intra-operatively

Secondary Outcomes (5)

  • Fluid input

    From immediately before induction of anesthesia until 48 hours after end of surgery

  • Fluid output

    From immediately before induction of anesthesia until 48 hours after end of surgery

  • Fluid balance

    From immediately before induction of anesthesia until 48 hours after end of surgery

  • Hemodynamics

    From immediately before induction of anesthesia until 48 hours after end of surgery

  • Co-administration of vasoactive drugs

    From enrolment until 48 hours after end of surgery

Study Arms (2)

1

EXPERIMENTAL

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

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)

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

Interventions

6% hydroxyethyl starch 130/0.4DRUG

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

1
6% hydroxyethyl starch 70/0.5 (Salinhes®)DRUG

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

2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Sapporo Medical University, School of Medicine

Sapporo, Hokkaido, 060-8543, Japan

Location

Kyushu University, Graduate School of Medical Sciences

Fukuoka, 812-8582, Japan

Location

Kobe University Graduate School of Medicine

Kobe, 650-0017, Japan

Location

Okayama University

Okayama, 700-8558, Japan

Location

Osaka University Graduate School of Medicine

Osaka, 565-0871, Japan

Location

Keio University School of Medicine

Tokyo, 160-8582, Japan

Location

Tokyo Women's Medical University

Tokyo, 162-8666, Japan

Location

MeSH Terms

Conditions

HypovolemiaHemorrhageBlood Loss, Surgical

Interventions

Hydroxyethyl Starch Derivatives

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsIntraoperative Complications

Intervention Hierarchy (Ancestors)

StarchDietary CarbohydratesCarbohydratesGlucansPolysaccharides

Study Officials

  • Akiyoshi Namiki, MD, PhD

    Emeritus Professor, Sapporo Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 6, 2009

First Posted

November 9, 2009

Study Start

November 1, 2009

Primary Completion

July 1, 2010

Study Completion

November 1, 2010

Last Updated

March 10, 2011

Record last verified: 2011-03

Locations

JP(7)