Brain HypoperfusionPhase 2NCT01192581
Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
A Phase 2 study testing hydroxyethyl starch 130/0.4 and sodium chloride injection in people with Brain Hypoperfusion, run by Xijing Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Brain Hypoperfusion
- What is being tested?
- hydroxyethyl starch 130/0.4 and sodium chloride injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Oct 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA.
- 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.
- 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.
Who cannot join
- Allergy to the components of Hydroxyethyl Starch
- Chronic liver disease (ALT > 120 or AST > 120)
- Chronic renal disease (Scr > 150 μmol/L)
- Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction
- Hemorrhagic stroke
- Pregnant and lactating women
Show all 12Show fewer
- Patients suffered from epilepsy or mental sickness
- Alcoholism or drug abuse
- hydroxyethyl starch or other artificial colloidal solution was used within 3 months.
- Patients participate in other clinical trial within 6 months
- Contraindication to CT perfusion imaging (i.e. contrast allergy, metformin use or Creatinine >160 μmol/l)
- Thrombus in lower limb vein
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Neurology , Xijing Hospital
Xi'an, Shaanxi, 710032
Gang Zhao, MD, 86 029 84775361, zhaogang@fmmu.edu.cn
Junliang Han, MD
About this study
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.
Read the 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.
- Conditions
- Brain Hypoperfusion
- Being tested
- hydroxyethyl starch 130/0.4 and sodium chloride injection
- Keywords
- brain hypoperfusion, Vuloven, computed tomography perfusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydroxyethyl starch 130/0.4 and sodium chloride injectionDrug
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
hydroxyethyl starch 130/0.4 and sodium chloride injectionDrug
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
hydroxyethyl starch 130/0.4 and sodium chloride injectionDrug
routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | routine treatment for brain hypoperfusion |
| Vuloven1 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg Receives: Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection |
| Vuloven2 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg Receives: Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection |
| Vuloven3 | Experimental | routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg Receives: Drug: hydroxyethyl starch 130/0.4 and sodium chloride injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy is evaluated based on the measure of CT perfusion parameters
Efficacy is evaluated based on the measure of CT perfusion parameters
Measured: 7 days
Secondary outcomes (2)
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales in those with cerebral infarction
Measured: 7 days
Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection
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.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain HypoperfusionStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gang Zhao, MD, Study director, the Department of Neurology , Xijing HospitalJunliang Han, MD, Principal investigator, Department of Neurology, Xijing HospitalFang Yang, MD, PhD, Principal investigator, Department of Neurology , Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192581
- Sponsor's protocol ID
- Vuloven001
- Status last verified
- Jun 2010
- First submitted
- 30 Aug 2010
- Last updated
- 1 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23110412
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection as Adjunctive Therapy in Subjects With Internal Carotid Artery Hypoperfusion
- ClinicalTrials.gov ID
- NCT01192581
- Acronym / sponsor ID
- Vuloven001
- Conditions
- Brain Hypoperfusion
- Keywords
- brain hypoperfusion, Vuloven, computed tomography perfusion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –routine treatment for brain hypoperfusion |
| Vuloven1 | Experimental | Drug: hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg |
| Vuloven2 | Experimental | Drug: hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg |
| Vuloven3 | Experimental | Drug: hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The degree of the branching arteries stenosis from the internal carotid artery is greater or equal to 70% confirmed by DSA.
- 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.
- 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.
Key exclusion criteria (12 listed)
- Allergy to the components of Hydroxyethyl Starch
- Chronic liver disease (ALT > 120 or AST > 120)
- Chronic renal disease (Scr > 150 μmol/L)
- Severe heart failure which correspond to NYHA heart failure classification class III or IV, or serious arrhythmia, myocardial infarction
- Hemorrhagic stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg | Drug | Vuloven1 |
| hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg | Drug | Vuloven2 |
| hydroxyethyl starch 130/0.4 and sodium chloride injectionroutine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg | Drug | Vuloven3 |
Primary outcome
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
2 secondary outcomes
Efficacy is evaluated based on scores on NIHSS, Bathl and modified Rankin Scales
Time frame: 7 days
Safety of hydroxyethyl starch 130/0.4 and sodium chloride injection
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2010.
- Derived from this study: PubMed 23110412Han 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gang Zhao, MD study director
the Department of Neurology , Xijing Hospital
Junliang Han, MD principal investigator
Department of Neurology, Xijing Hospital
Fang Yang, MD, PhD principal investigator
Department of Neurology , Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hydroxyethyl starch 130/0.4 and sodium chloride injection in people with Brain Hypoperfusion, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gang Zhao, MD (86 029 84775361, zhaogang@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy is evaluated based on the measure of CT perfusion parameters (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01192581, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2010.