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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

August 21, 2012
November 28, 2013
September 2012
September 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01684462 on ClinicalTrials.gov Archive Site
  • 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
  • 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.
  • mRS favorable outcome [ Time Frame: at 3 months ] [ Designated as safety issue: Yes ]
    Comparison of the global functional outcome on 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
Not Provided
Not Provided
 
The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Infarction
  • 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
  • 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
  • Experimental: Human Serum Albumin 20
    Human Serum Albumin 20% 100cc intravenously infused over 4~8h
    Intervention: Biological: Human Serum Albumin 20
  • Placebo Comparator: 0.9 % Normal saline
    Treatment with same volume of normal saline
    Intervention: Drug: 0.9 % Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
September 2014
September 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01684462
AL_IIT_01
Yes
Kwang Soo Lee, Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
Green Cross Corporation
Principal Investigator: Kwang Soo Lee, M.D, Ph.D Seoul St. Mary's Hospital
Seoul St. Mary's Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP