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

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Brain Hypoperfusion

Treatments: Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01192581

Vuloven001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 4 patient groups

control

No Intervention group

Description:

routine treatment for brain hypoperfusion

Vuloven1

Experimental group

Description:

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

Treatment:

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Vuloven2

Experimental group

Description:

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

Treatment:

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Vuloven3

Experimental group

Description:

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

Treatment:

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection

Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection