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

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.

Study Overview

• Status: Terminated
• Conditions: Cerebral Infarction
• Intervention / Treatment: Biological: Human Serum Albumin 20; Drug: 0.9 % Normal Saline

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
• Enrollment (Actual): 2
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggido
    • Suwon, Gyeonggido, Korea, Republic of
      • St. Vincent's Hospital
  • Seoul
    • Mok-dong, Seoul, Korea, Republic of, 158-710
      • Ewha Womans University Mokdong Hospital
    • Seocho-Gu, Seoul, Korea, Republic of, 137-701
      • Seoul St. Mary's Hospital
    • Yeongdeungpo-Gu, Seoul, Korea, Republic of, 150-713
      • Yeoudo St. Mary's hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 0.9 % Normal Saline ChoongWae INJ. 100ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average change in NIHSS	Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days	at 14±3days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NIHSS Score	Comparison of NIHSS score between the control and ALbumin group at 14±3days	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.	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.	at 3 months
Volume difference on diffusion MRI	Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days	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	at 4±1days

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Collaborators: Green Cross Corporation
• Investigators: Principal Investigator: Kwang Soo Lee, M.D, Ph.D, Seoul St. Mary's Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Anticipated): September 1, 2014
• Study Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: August 21, 2012
• First Submitted That Met QC Criteria: September 12, 2012
• First Posted (Estimate): September 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 2, 2013
• Last Update Submitted That Met QC Criteria: November 28, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Acute Ischemic Stroke; Albumin
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Ischemic Stroke; Cerebral Infarction
• Other Study ID Numbers: AL_IIT_01