HypovolemiaPhase 3NCT01010022
Trial of 6% HES130/0.4
A Phase 3 study testing 6% hydroxyethyl starch 130/0.4 and 6% hydroxyethyl starch 70/0.5 (Salinhes®) in people with Hypovolemia and Hemorrhage, run by Fresenius Kabi Japan at 7 sites in Japan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypovolemia, Hemorrhage
- What is being tested?
- 6% hydroxyethyl starch 130/0.4 and 6% hydroxyethyl starch 70/0.5 (Salinhes®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 7 sitesJapan
- Study dates
- Nov 2009to Nov 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
- Patients with a body weight (BW) ≥ 50 kg
Who cannot join
- 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
Show all 9Show fewer
- Intracranial bleeding
- Severe hypernatremia
- Severe hyperchloremia
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Kyushu University, Graduate School of Medical Sciences
Fukuoka, 812-8582
Kobe University Graduate School of Medicine
Kobe, 650-0017
Okayama University
Okayama, 700-8558
Osaka University Graduate School of Medicine
Osaka, 565-0871
Sapporo Medical University, School of Medicine
Sapporo, Hokkaido, 060-8543
Keio University School of Medicine
Tokyo, 160-8582
Tokyo Women's Medical University
Tokyo, 162-8666
About this study
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
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.
- Conditions
- Hypovolemia, Hemorrhage
- Being tested
- 6% hydroxyethyl starch 130/0.4, 6% hydroxyethyl starch 70/0.5 (Salinhes®)
- Keywords
- hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
- Medical subject headings
- Hypovolemia, Hemorrhage, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
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)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) Receives: 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) Receives: Drug: 6% hydroxyethyl starch 70/0.5 (Salinhes®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume of colloid solution infused during investigational period (= intra-operatively)
Measured: Intra-operatively
Secondary outcomes (5)
Fluid input
Measured: From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid output
Measured: From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid balance
Measured: From immediately before induction of anesthesia until 48 hours after end of surgery
Hemodynamics
Measured: From immediately before induction of anesthesia until 48 hours after end of surgery
Co-administration of vasoactive drugs
Measured: From enrolment until 48 hours after end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypovolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fresenius Kabi Japan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Akiyoshi Namiki, MD, PhD, Study chair, Emeritus Professor, Sapporo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01010022
- Sponsor's protocol ID
- HS-13-02-JP
- Status last verified
- Mar 2011
- First submitted
- 6 Nov 2009
- Last updated
- 10 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01010022
- Acronym / sponsor ID
- HS-13-02-JP
- Conditions
- Hypovolemia, Hemorrhage
- Keywords
- hypovolemia, surgical blood loss, orthopedic procedures, Treatment of reduced circulating blood volume (hypovolemia) including massive hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Fresenius Kabi JapanIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 9 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: 6% hydroxyethyl starch 130/0.4Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) |
| 2 | Active comparator | 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) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with an expected blood loss of ≥ 300 mL undergoing elective orthopedic surgery
- Patients with a body weight (BW) ≥ 50 kg
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6% hydroxyethyl starch 130/0.4Up to 1000mL 6% hydroxyethyl starch 130/0.4 solution i.v., intra-operatively (from start of surgery until end of surgery) | Drug | 1 |
| 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) | Drug | 2 |
Primary outcome
Volume of colloid solution infused during investigational period (= intra-operatively)
Time frame: Intra-operatively
5 secondary outcomes
Fluid input
Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid output
Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery
Fluid balance
Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery
Hemodynamics
Time frame: From immediately before induction of anesthesia until 48 hours after end of surgery
Co-administration of vasoactive drugs
Time frame: From enrolment until 48 hours after end of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Akiyoshi Namiki, MD, PhD study chair
Emeritus Professor, Sapporo Medical University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 6% hydroxyethyl starch 130/0.4 and 6% hydroxyethyl starch 70/0.5 (Salinhes®) in people with Hypovolemia and Hemorrhage, run by Fresenius Kabi Japan at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volume of colloid solution infused during investigational period (= intra-operatively) (time frame: Intra-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2011.