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

NCT ID: NCT01192581

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Brain Hypoperfusion

Keywords

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brain hypoperfusion Vuloven computed tomography perfusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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control

routine treatment for brain hypoperfusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Vuloven1

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg

Group Type EXPERIMENTAL

hydroxyethyl starch 130/0.4 and sodium chloride injection

Intervention Type DRUG

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg

Vuloven2

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg

Group Type EXPERIMENTAL

hydroxyethyl starch 130/0.4 and sodium chloride injection

Intervention Type DRUG

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg

Vuloven3

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg

Group Type EXPERIMENTAL

hydroxyethyl starch 130/0.4 and sodium chloride injection

Intervention Type DRUG

routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg

Interventions

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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

Intervention Type 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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xijing Hospital

Principal Investigators

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Gang Zhao, MD

Role: STUDY_DIRECTOR

the Department of Neurology , Xijing Hospital

Junliang Han, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology, Xijing Hospital

Fang Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Neurology , Xijing Hospital

Locations

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Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Gang Zhao, MD

Role: CONTACT

Phone: 86 029 84775361

Email: [email protected]

Facility Contacts

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Gang Zhao, MD

Role: primary

References

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Han J, Yang F, Jiang W, Zhang G, Liu Z, Liu X, Xia F, Bai Y, He J, Chao M, Zhao G. Hydroxyethyl starch 130/0.4 and sodium chloride injection as adjunctive therapy in patients with cerebral hypoperfusion. BMC Neurol. 2012 Oct 30;12:127. doi: 10.1186/1471-2377-12-127.

Reference Type DERIVED
PMID: 23110412 (View on PubMed)

Other Identifiers

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Vuloven001

Identifier Type: -

Identifier Source: org_study_id