Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion

October 28, 2010 updated by: Xijing Hospital
The aim of this study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will recruit 120 male and female patients between 18 and 75 years of age who are diagnosed with brain hypoperfusion within the unilateral arteries branching from the internal carotid artery with or without cerebral infarction. All subjects are taking up to routine treatment medications.

The purpose of the study is to evaluate the effectiveness, safety and tolerability of consistent dosages of the study drug (hydroxyethyl starch 130/0.4 and sodium chloride injection, Vuloven) administrated intravenously for 7 days.

Each patient who qualifies and chooses to participate in the study will be randomly assigned into treatment groups (consistent dose of hydroxyethyl starch 130/0.4 and sodium chloride injection of 500 ml/day, 1000 ml/day or 1500 ml/day) or control group (placebo control).

The parameters of clinic visits will include a medical history, physical exam, clinical laboratory tests, magnetic resonance imaging (MRI), using T1-weighted scan, T2-weighted scan and diffusion-weighted imaging (DWI), digital subtraction angiography (DSA), and computed tomography (CT) perfusion.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Department of Neurology , Xijing Hospital
        • Contact:
        • Principal Investigator:
          • Junliang Han, MD
        • Sub-Investigator:
          • Fang Yang, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA.
  2. Before hydroxyethyl starch 130/0.4 and sodium chloride injection-additional treatment, CT perfusion shows that time to peak (TTP) in lesion area is more than that in corresponding area of contralateral hemisphere.
  3. If cerebral infarction appears, the time course should be less than 48h, NIH stroke scale: 3-20, and MRI+DWI shows ischemic stroke due to large artery atherosclerosis.

Exclusion Criteria:

  1. Allergy to the components of Hydroxyethyl Starch
  2. Chronic liver disease (ALT > 120 or AST > 120)
  3. Chronic renal disease (Scr > 150 μmol/L)
  4. Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction
  5. Hemorrhagic stroke
  6. Pregnant and lactating women
  7. Patients suffered from epilepsy or mental sickness
  8. Alcoholism or drug abuse
  9. hydroxyethyl starch or other artificial colloidal solution was used within 3 months.
  10. Patients participate in other clinical trial within 6 months
  11. Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine >160 μmol/l)
  12. Thrombus in lower limb vein

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NO_INTERVENTION: control
routine treatment for brain hypoperfusion
EXPERIMENTAL: Vuloven1
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
EXPERIMENTAL: Vuloven2
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
EXPERIMENTAL: Vuloven3
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Efficacy is evaluated based on the measure of CT perfusion parameters
Time Frame: 7 days
Efficacy is evaluated based on the measure of CT perfusion parameters
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales
Time Frame: 7 days
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales in those with cerebral infarction
7 days
Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection
Time Frame: 7 days
Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection was evaluated with the monitoring of adverse events (AEs), vital signs, and clinical laboratory data.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Junliang Han, MD, Department of Neurology, Xijing Hospital
  • Principal Investigator: Fang Yang, MD, PhD, Department of Neurology , Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2010

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Vuloven001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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