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The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke (ALbumin)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01684462
Recruitment Status : Terminated
First Posted : September 13, 2012
Last Update Posted : December 2, 2013
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Kwang Soo Lee, Seoul St. Mary's Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Biological: Human Serum Albumin 20 Drug: 0.9 % Normal Saline Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : September 2012
Estimated Primary Completion Date : September 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: Human Serum Albumin 20
Human Serum Albumin 20% 100cc intravenously infused over 4~8h
 Biological: Human Serum Albumin 20
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
Other Name: Human Serum Albumin Injection 20% 100ml Greencross
Placebo Comparator: 0.9 % Normal saline
Treatment with same volume of normal saline
 Drug: 0.9 % Normal Saline
Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset
Other Name: 0.9 % Normal Saline ChoongWae INJ. 100ml


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. NIHSS Score [ Time Frame: at 14±3days ]
    Comparison of NIHSS score between the control and ALbumin group at 14±3days

  2. Proportion of patients with improvement by NIHSS [ Time Frame: at 14±3days ]
    Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.

  3. modified Rankin Scale(mRS) favorable outcome [ Time Frame: at 3 months ]
    Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.

  4. Volume difference on diffusion MRI [ Time Frame: at 4 days±1days ]
    Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days

  5. Recurrent new ischemic lesions on diffusion MRI [ Time Frame: at 4±1days ]
    Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01684462


Locations
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Korea, Republic of
St. Vincent's hospital
Suwon, Gyeonggido, Korea, Republic of
Ewha Womans University Mokdong Hospital
Mok-dong, Seoul, Korea, Republic of, 158-710
Seoul St. Mary's Hospital
Seocho-Gu, Seoul, Korea, Republic of, 137-701
Yeoudo St. Mary's hospital
Yeongdeungpo-Gu, Seoul, Korea, Republic of, 150-713
Sponsors and Collaborators
Seoul St. Mary's Hospital
Green Cross Corporation
Investigators
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Principal Investigator: Kwang Soo Lee, M.D, Ph.D Seoul St. Mary's Hospital
More Information
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Responsible Party: Kwang Soo Lee, Neurology Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01684462    
Other Study ID Numbers: AL_IIT_01
First Posted: September 13, 2012    Key Record Dates
Last Update Posted: December 2, 2013
Last Verified: November 2013
Keywords provided by Kwang Soo Lee, Seoul St. Mary's Hospital:
Acute Ischemic Stroke
Albumin
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebral Infarction
Infarction
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia