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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

120

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Xijing Hospital

Investigators

  • 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

August 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2011

Study Completion (ANTICIPATED)

October 1, 2011

Study Registration Dates

First Submitted

August 30, 2010

First Submitted That Met QC Criteria

August 30, 2010

First Posted (ESTIMATE)

September 1, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2010

Last Update Submitted That Met QC Criteria

October 28, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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