Plasma Volume Substitution (Hypovolemia) Including Massive HemorrhagePhase 3NCT01127477

Study to Obtain Volume Effect and Safety Data on 6 % Hydroxyethyl Starch 130/0.4 in Pediatric and Adult Patients Undergoing Major Elective Surgery

A Phase 3 study testing 1: Hydroxyethyl starch 130/0.4, 6 % in people with Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage, run by Fresenius Kabi Japan at 4 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
What is being tested?: 1: Hydroxyethyl starch 130/0.4, 6 %
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 4 sitesJapan
Study dates: May 2010to Dec 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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients undergoing major elective surgery
Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
Adult patients: Routine measurement of Central Venous Pressure (CVP)

Who cannot join

Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
ASA classification ≥ IV
Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
Known bleeding disorders
Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.

Trial locations and contacts

4 sites in 1 country.

Japan4 sites

Okayama University
Okayama, 700-8558
Sapporo Medical University, School of Medicine
Sapporo, Hokkaido, 060-8543
National Center for Child Health and Development
Tokyo, 157-8535
Tokyo Women's Medical University
Tokyo, 162-8666

Other trials in Japan

About this study

Official title: Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study

The study shall evaluate the volume effect and safety of 6 % hydroxyethyl starch 130/0.4 for restoration and maintenance of hemodynamics during the investigational period in patients undergoing major elective surgery. Up to 50 mL 6% hydroxyethyl starch/kg body weight will be administered from start of surgery until two hours after end of surgery. The study hypothesis is that 6 % hydroxyethyl starch 130/0.4 will have a reliable volume effect and can be safely administered up to the dose limit.

Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Being tested: 1: Hydroxyethyl starch 130/0.4, 6 %
Keywords: Hypovolemia, surgical blood loss
Medical subject headings: Hypovolemia, Blood Loss, Surgical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

1: Hydroxyethyl starch 130/0.4, 6 %Drug
1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.

Study groups in NCT01127477
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: 1: Hydroxyethyl starch 130/0.4, 6 %

What is being measured

The primary outcome is the main question the study is designed to answer.

Volume Effect
Volume effect will be assessed by evaluating the following parameter:
1. Saved albumin: For adult patients: Amount of 6 % hydroxyethyl starch 130/0.4 (HES130) administered during surgery once 1000 mL of HES130 are exceeded. For pediatric patients: Amount of HES130 administered during surgery once 10 mL HES130/kg body weight are exceeded.
2. Time course of hemodynamic stability
Measured: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery

Secondary outcomes (11)

Fluid Balance
Fluid balance = fluid input vs. fluid output
Measured: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
Hemodynamics
Measured: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
CVP
Central venous pressure (CVP); not mandatory for pediatric patients
Measured: Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
Hematology
Measured: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery
Clinical Chemistry
Measured: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery
Hemostasis
Measured: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
Body Temperature
Measured: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
ECG
Not mandatory for pediatric patients
Measured: Screening, 2 hours and 24 hours after end of surgery
Urinalysis
Not mandatory for pediatric patients
Measured: Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
Local and Systemic Tolerance
Measured: After each administration of study drug
(Serious) Adverse Events
Measured: From signing informed consent until 28 days follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Dec 2010

First posted21 May 2010 (estimated)
Study startMay 2010
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Plasma Volume Substitution (Hypovolemia) Including Massive HemorrhageStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01127477
Sponsor's protocol ID: HE06-008-CP3
Status last verified: Mar 2012
First submitted: 17 May 2010
Last updated: 26 Jun 2012
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Examination of Volume Effect and Safety of 6 % Hydroxyethyl Starch 130/0.4 in Patients Undergoing Major Elective Surgery - an Uncontrolled, Open-labelled, Multi-centre Study
ClinicalTrials.gov ID: NCT01127477
Acronym / sponsor ID: HE06-008-CP3
Conditions: Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage
Keywords: Hypovolemia, surgical blood loss
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Fresenius Kabi JapanIndustry (pharma, biotech, devices)
Study start: May 2010
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 21 May 2010 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
1	Experimental	Drug: 1: Hydroxyethyl starch 130/0.4, 6 %

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Patients undergoing major elective surgery
Adults patients (≥20 years of age): expected blood loss of ≥ 1000mL Pediatric patients (<20 years of age): expected blood loss ≥ 15 mL/kg
Adult patients: Routine measurement of Central Venous Pressure (CVP)

Key exclusion criteria (5 listed)

Known or suspected allergy to hydroxyethyl starch, including its ingredients (inclusive corn) and related drugs
ASA classification ≥ IV
Adult patients: renal failure with oliguria (<400 mL urin /24hours) and anuria Pediatric patients: renal failure with oliguria and anuria not related to hypovolemia
Known bleeding disorders
Other contra-indications according to the current SmPC of Voluven 6% solution for infusion.

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
1: Hydroxyethyl starch 130/0.4, 6 %1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.	Drug	1

Primary outcome

Volume Effect
Time frame: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery
Volume effect will be assessed by evaluating the following parameter: 1. Saved albumin: For adult patients: Amount of 6 % hydroxyethyl starch 130/0.4 (HES130) administered during surgery once 1000 mL of HES130 are exceeded. For pediatric patients: Amount of HES130 administered during surgery once 10 mL HES130/kg body weight are exceeded. 2. Time course of hemodynamic stability

11 secondary outcomes

Fluid Balance
Time frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
Hemodynamics
Time frame: From one day before (pediatric patients)/ immediately before (adults) induction of anesthesia until 48 hours after end of surgery
CVP
Time frame: Immediately before or after induction of anesthesia (depending on routine procedures), every hour after skin incision, and 2 hours after surgery
Hematology
Time frame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, every hour after skin incision (adults), end of surgery (adults), 2 hours and 24 hours after end of surgery
Clinical Chemistry
Time frame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours after end of surgery (pediatric patients), and 24 hours after end of surgery
Hemostasis
Time frame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery (adults), 2 hours and 24 hours after end of surgery
Body Temperature
Time frame: One day before (pediatric patients)/ immediately before (adults) induction of anesthesia, end of surgery, 2 hours and 24 hours after end of surgery
ECG
Time frame: Screening, 2 hours and 24 hours after end of surgery
Urinalysis
Time frame: Immediately before or after induction of anesthesia (depending on routine procedures) and 24 hours after surgery
Local and Systemic Tolerance
Time frame: After each administration of study drug
(Serious) Adverse Events
Time frame: From signing informed consent until 28 days follow up

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 26 Jun 2012.

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; CEO, Otaru City Hospitals, Hokkaido, Japan

4 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 1: Hydroxyethyl starch 130/0.4, 6 % in people with Plasma Volume Substitution (Hypovolemia) Including Massive Hemorrhage, run by Fresenius Kabi Japan at 4 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 3 inclusion and 5 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 26 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 Effect (time frame: Saved albumin: during surgery; Time course of hemodynamic stability: from end of surgery until 24 h after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01127477.

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 26 Jun 2012.