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

Primary Purpose

Cerebral Infarction

Status
Terminated
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Human Serum Albumin 20
0.9 % Normal Saline
Sponsored by
Seoul St. Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Infarction focused on measuring Acute Ischemic Stroke, Albumin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Vincent's hospital
  • Ewha Womans University Mokdong Hospital
  • Seoul St. Mary's Hospital
  • Yeoudo St. Mary's hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Human Serum Albumin 20

0.9 % Normal saline

Arm Description

Human Serum Albumin 20% 100cc intravenously infused over 4~8h

Treatment with same volume of normal saline

Outcomes

Primary Outcome Measures

Average change in NIHSS
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
Comparison of NIHSS score between the control and ALbumin group 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.
modified Rankin Scale(mRS) favorable outcome
Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.
Volume difference on diffusion MRI
Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±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

Full Information

First Posted
August 21, 2012
Last Updated
November 28, 2013
Sponsor
Seoul St. Mary's Hospital
Collaborators
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01684462
Brief Title
The Efficacy and Safety Study of ALbumin Therapy in Acute Ischemic Stroke
Acronym
ALbumin
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 Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul St. Mary's Hospital
Collaborators
Green Cross Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction
Keywords
Acute Ischemic Stroke, Albumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Human Serum Albumin 20
Arm Type
Experimental
Arm Description
Human Serum Albumin 20% 100cc intravenously infused over 4~8h
Arm Title
0.9 % Normal saline
Arm Type
Placebo Comparator
Arm Description
Treatment with same volume of normal saline
Intervention Type
Biological
Intervention Name(s)
Human Serum Albumin 20
Other Intervention Name(s)
Human Serum Albumin Injection 20% 100ml Greencross
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
0.9 % Normal Saline
Other Intervention Name(s)
0.9 % Normal Saline ChoongWae INJ. 100ml
Intervention Description
Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset
Primary Outcome Measure Information:
Title
Average change in NIHSS
Description
Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h~0days) and 14±3days
Time Frame
at 14±3days
Secondary Outcome Measure Information:
Title
NIHSS Score
Description
Comparison of NIHSS score between the control and ALbumin group at 14±3days
Time Frame
at 14±3days
Title
Proportion of patients with improvement by NIHSS
Description
Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.
Time Frame
at 14±3days
Title
modified Rankin Scale(mRS) favorable outcome
Description
Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h~0days) and 3 months.
Time Frame
at 3 months
Title
Volume difference on diffusion MRI
Description
Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days
Time Frame
at 4 days±1days
Title
Recurrent new ischemic lesions on diffusion MRI
Description
Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI
Time Frame
at 4±1days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwang Soo Lee, M.D, Ph.D
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's hospital
City
Suwon
State/Province
Gyeonggido
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Mok-dong
State/Province
Seoul
ZIP/Postal Code
158-710
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital
City
Seocho-Gu
State/Province
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Yeoudo St. Mary's hospital
City
Yeongdeungpo-Gu
State/Province
Seoul
ZIP/Postal Code
150-713
Country
Korea, Republic of

12. IPD Sharing Statement

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

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