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

• ClinicalTrials.gov Identifier: NCT01684462
• Recruitment Status: Terminated
• First Posted: September 13, 2012
• Last Update Posted: December 2, 2013
• Sponsor: Seoul St. Mary's Hospital
• Collaborator: Green Cross Corporation
• Information provided by (Responsible Party): Kwang Soo Lee, Seoul St. Mary's Hospital

Tracking Information

• First Submitted Date: August 21, 2012
• First Posted Date: September 13, 2012
• Last Update Posted Date: December 2, 2013
• Study Start Date: September 2012
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 12, 2012)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 13, 2012)

• NIHSS Score [ Time Frame: at 14±3days ]
  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 ]
  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 ]
  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 ]
  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 ]
  Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI

Original Secondary Outcome Measures (submitted: September 12, 2012)

• NIHSS Score [ Time Frame: at 14±3days ]
  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 ]
  Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.
• mRS favorable outcome [ Time Frame: at 3 months ]
  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 ]
  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 ]
  Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke
• 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.
• 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.

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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cerebral Infarction

Intervention

• 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

Study Arms

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: November 28, 2013): 2
• Original Estimated Enrollment (submitted: September 12, 2012): 56
• Estimated Study Completion Date: September 2014
• Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT01684462
• Other Study ID Numbers: AL_IIT_01
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Kwang Soo Lee, Seoul St. Mary's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Seoul St. Mary's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Green Cross Corporation

Investigators

• Principal Investigator: Kwang Soo Lee, M.D, Ph.D; Seoul St. Mary's Hospital

• PRS Account: Seoul St. Mary's Hospital
• Verification Date: November 2013