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

NCT ID: NCT01684462

Last Updated: 2013-12-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Cerebral Infarction

Keywords

Acute Ischemic Stroke; Albumin

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Human Serum Albumin 20

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

Group Type: EXPERIMENTAL

Human Serum Albumin 20

Intervention Type: BIOLOGICAL

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

0.9 % Normal saline

Treatment with same volume of normal saline

Group Type: PLACEBO_COMPARATOR

0.9 % Normal Saline

Intervention Type: DRUG

Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4\~8h, commencing within 12 hours of stroke onset

Interventions

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

Intervention Type: BIOLOGICAL

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

Intervention Type: DRUG

Other Intervention Names

Human Serum Albumin Injection 20% 100ml Greencross; 0.9 % Normal Saline ChoongWae INJ. 100ml

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Green Cross Corporation

INDUSTRY

Sponsor Role: collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kwang Soo Lee

Neurology Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kwang Soo Lee, M.D, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

St. Vincent's hospital

Suwon, Gyeonggido, South Korea

Ewha Womans University Mokdong Hospital

Mokdong, Seoul, South Korea

Seoul St. Mary's Hospital

Seocho-Gu, Seoul, South Korea

Yeoudo St. Mary's hospital

Yeongdeungpo-gu, Seoul, South Korea

Countries

South Korea

Other Identifiers

AL_IIT_01

Identifier Type: -

Identifier Source: org_study_id