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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01192581
First received: August 30, 2010
Last updated: October 28, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Brain Hypoperfusion
Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Efficacy is evaluated based on the measure of CT perfusion parameters [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Efficacy is evaluated based on the measure of CT perfusion parameters


Secondary Outcome Measures:
  • Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales in those with cerebral infarction

  • Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 120
Study Start Date: August 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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 1000mg
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 1500mg

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01192581

Contacts
Contact: Gang Zhao, MD 86 029 84775361 zhaogang@fmmu.edu.cn

Locations
China, Shaanxi
Department of Neurology , Xijing Hospital Recruiting
Xi'an, Shaanxi, China, 710032
Contact: Gang Zhao, MD    86 029 84775361    zhaogang@fmmu.edu.cn   
Principal Investigator: Junliang Han, MD         
Sub-Investigator: Fang Yang, MD, PhD         
Sponsors and Collaborators
Xijing Hospital
Investigators
Study Director: Gang Zhao, MD the Department of Neurology , Xijing Hospital
Principal Investigator: Junliang Han, MD Department of Neurology, Xijing Hospital
Principal Investigator: Fang Yang, MD, PhD Department of Neurology , Xijing Hospital
  More Information

No publications provided by Xijing Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: the neurology department of Xijing Hospital, Xijing Hospital
ClinicalTrials.gov Identifier: NCT01192581     History of Changes
Other Study ID Numbers: Vuloven001
Study First Received: August 30, 2010
Last Updated: October 28, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
brain hypoperfusion
Vuloven
computed tomography perfusion

Additional relevant MeSH terms:
Hetastarch
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014