Cerebral InfarctionPhase 2ALbuminNCT01684462
The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke
A Phase 2 study testing Human Serum Albumin 20 and 0.9 % Normal Saline in people with Cerebral Infarction, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
Trial summary
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebral Infarction
- What is being tested?
- Human Serum Albumin 20 and 0.9 % Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 4 sitesSouth Korea
- Study dates
- Sep 2012to Sep 2014
- 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
- At least 18 years of age less than 75 years old
- Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke
- 5 ≤ NIHSS score < 15
- Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily
Who cannot join
- Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.
- Patients with cardiac edema or pulmonary edema.
- Medical history of myocardial infarction within the past six months.
- Patients who have serious aortic stenosis and mitral valve stenosis.
- Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L)
- Those Who had cardiac surgery.
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- Onset of cerebral infarction within the past three months.
- Before onset of cerebral infarction, patients who were diagnosed as Historical mRS ≥ 2.
- Patients who received treatment of thrombolysis or who planned for treatment of thrombolysis.
- Acute tachyarrhythmia or bradyarrhythmia with hemodynamic instability on admission.
- Acute or chronic lung disease requiring supplemental O2 therapy on admission
- Severe anemia (Hb < 8.0)
- Severe dehydration (defined as decreased skin turgor, dry oral mucous membrane, tachycardia(>100/min), and oliguria)
- Fever, defined as core body temperature>37.5 ℃
- Serum creatinine > 2.0 mg/dL
- History of allergy to albumin.
- Patients who have side effects of albumin (hyperergia to shock, fever, facial flushing,urticarial, algor, lumbodynia)
- Pregnancy
- Patients who are in life-threatening or stupor coma situation.
- Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on admission CT or MRI scan.
- Patients who are not the normal, excesses of circulating blood.
- Haemolytic anemia, anemia due to blood loss.
- Immunodeficiency disease, immunosuppression.
- Blood pressure higher than 180/110 mmHg on admission.
Trial locations and contacts
4 sites in 1 country.
South Korea4 sites
Ewha Womans University Mokdong Hospital
Mokdong, Seoul, 158-710
Seoul St. Mary's Hospital
Seocho-Gu, Seoul, 137-701
St. Vincent's hospital
Suwon, Gyeonggido
Yeoudo St. Mary's hospital
Yeongdeungpo-gu, Seoul, 150-713
About this study
Official title: A Phase IIB Placebo Comparative, Double Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of ALbumin Therapy in Acute Ischemic Stroke Patients in Korea.
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.
Read the detailed description
According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke was accounted for a large proportion of cause of death among adults, as well as higher mortality, severe sequelae. These stroke in acute phase showed neurological deterioration over 50% of the patients after beginning of treatment and the sequelae resulting in that the nervous tissue was not regenerated is regarded as irreversible changes.
The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of placebo (saline solution (0.9% normal saline)) administered to the control group will be compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic stroke.
- Conditions
- Cerebral Infarction
- Being tested
- Human Serum Albumin 20, 0.9 % Normal Saline
- Keywords
- Acute Ischemic Stroke, Albumin
- Medical subject headings
- Cerebral Infarction, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human Serum Albumin 20Biological
Also called Human Serum Albumin Injection 20% 100ml Greencross
Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset
0.9 % Normal SalineDrug
Also called 0.9 % Normal Saline ChoongWae INJ. 100ml
Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset
| Study group | Role | What they receive |
|---|---|---|
| Human Serum Albumin 20 | Experimental | Human Serum Albumin 20% 100cc intravenously infused over 4~8h Receives: Biological: Human Serum Albumin 20 |
| 0.9 % Normal saline | Placebo comparator | Treatment with same volume of normal saline Receives: Drug: 0.9 % Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average change in NIHSS
Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days
Measured: at 14±3days
Secondary outcomes (5)
NIHSS Score
Comparison of NIHSS score between the control and ALbumin group at 14±3days
Measured: at 14±3days
Proportion of patients with improvement by NIHSS
Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.
Measured: at 14±3days
modified Rankin Scale(mRS) favorable outcome
Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.
Measured: at 3 months
Volume difference on diffusion MRI
Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days
Measured: at 4 days±1days
Recurrent new ischemic lesions on diffusion MRI
Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI
Measured: at 4±1days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Principal investigator, Kwang Soo Lee, Seoul St. Mary's Hospital
- Investigators
- Kwang Soo Lee, M.D, Ph.D, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01684462
- Sponsor's protocol ID
- AL_IIT_01
- Acronym
- ALbumin
- Status last verified
- Nov 2013
- First submitted
- 21 Aug 2012
- Last updated
- 2 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIB Placebo Comparative, Double Blinded, Randomized, Multi-center Study to Evaluate the Efficacy and Safety of ALbumin Therapy in Acute Ischemic Stroke Patients in Korea.
- ClinicalTrials.gov ID
- NCT01684462
- Acronym / sponsor ID
- ALbumin / AL_IIT_01
- Conditions
- Cerebral Infarction
- Keywords
- Acute Ischemic Stroke, Albumin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- Sep 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 13 Sep 2012 (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.
In this clinical study, the efficacy and safety of ALbumin is to be evaluated for the patients occurred within 12 hours of acute ischemic stroke.
Detailed description
According to the statistics of the cause of death in 2008 by the Statistics Korea, the stroke was accounted for a large proportion of cause of death among adults, as well as higher mortality, severe sequelae. These stroke in acute phase showed neurological deterioration over 50% of the patients after beginning of treatment and the sequelae resulting in that the nervous tissue was not regenerated is regarded as irreversible changes.
The test group administered 20% albumin based on 1.25g/kg (up to 100g (500ml) over 80kg body weight) to the patients occurred within 12 hours of the onset of symptoms and equal amount of placebo (saline solution (0.9% normal saline)) administered to the control group will be compared to evaluate the efficacy and safety of ALbumin for the patients with acute ischemic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Human Serum Albumin 20 | Experimental | Biological: Human Serum Albumin 20Human Serum Albumin 20% 100cc intravenously infused over 4~8h |
| 0.9 % Normal saline | Placebo comparator | Drug: 0.9 % Normal SalineTreatment with same volume of normal saline |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age less than 75 years old
- Patients who can be administered ALbumin within 12hours of onset of acute ischemic stroke
- 5 ≤ NIHSS score < 15
- Patients who are agreed by guardian or legal representative in case that patients have no ability to join study voluntarily
Key exclusion criteria (24 listed)
- Medical history of congestive heart failure or patients who are judged congestive heart failure on admission.
- Patients with cardiac edema or pulmonary edema.
- Medical history of myocardial infarction within the past six months.
- Patients who have serious aortic stenosis and mitral valve stenosis.
- Signs or symptoms of acute MI on admission (Serum troponin level ≤0.1 ug/L)
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 |
|---|---|---|
| Human Serum Albumin 20Also: Human Serum Albumin Injection 20% 100ml GreencrossHuman Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset | Biological | Human Serum Albumin 20 |
| 0.9 % Normal SalineAlso: 0.9 % Normal Saline ChoongWae INJ. 100mlInfusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset | Drug | 0.9 % Normal saline |
Primary outcome
Average change in NIHSS
Time frame: at 14±3days
Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days
5 secondary outcomes
NIHSS Score
Time frame: at 14±3days
Proportion of patients with improvement by NIHSS
Time frame: at 14±3days
modified Rankin Scale(mRS) favorable outcome
Time frame: at 3 months
Volume difference on diffusion MRI
Time frame: at 4 days±1days
Recurrent new ischemic lesions on diffusion MRI
Time frame: at 4±1days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2013.
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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.
Kwang Soo Lee, M.D, Ph.D principal investigator
Seoul St. Mary's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human Serum Albumin 20 and 0.9 % Normal Saline in people with Cerebral Infarction, run by Seoul St. Mary's Hospital at 4 sites in South Korea.
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 4 inclusion and 24 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: stopped early, as of the sponsor's last update on 2 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average change in NIHSS (time frame: at 14±3days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Dec 2013.