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

This study has been terminated.
Sponsor:
Collaborator:
Green Cross Corporation
Information provided by (Responsible Party):
Kwang Soo Lee, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01684462
First received: August 21, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Cerebral Infarction
Biological: Human Serum Albumin 20
Drug: 0.9 % Normal Saline
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: 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.

Resource links provided by NLM:


Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Average change in NIHSS [ Time Frame: at 14±3days ] [ Designated as safety issue: Yes ]
    Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days


Secondary Outcome Measures:
  • NIHSS Score [ Time Frame: at 14±3days ] [ Designated as safety issue: Yes ]
    Comparison of NIHSS score between the control and ALbumin group at 14±3days

  • Proportion of patients with improvement by NIHSS [ Time Frame: at 14±3days ] [ Designated as safety issue: Yes ]
    Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.

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

  • Volume difference on diffusion MRI [ Time Frame: at 4 days±1days ] [ Designated as safety issue: Yes ]
    Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days

  • Recurrent new ischemic lesions on diffusion MRI [ Time Frame: at 4±1days ] [ Designated as safety issue: Yes ]
    Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI


Enrollment: 2
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01684462

Locations
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
Principal Investigator: Kwang Soo Lee, M.D, Ph.D Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Kwang Soo Lee, Neurology Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT01684462     History of Changes
Other Study ID Numbers: AL_IIT_01
Study First Received: August 21, 2012
Last Updated: November 28, 2013
Health Authority: United States: Food and Drug Administration
Korea: Food and Drug Administration
Korea: Institutional Review Board

Keywords provided by Seoul St. Mary's Hospital:
Acute Ischemic Stroke
Albumin

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Albunex
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014