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

Information source: Seoul St. Mary's Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cerebral Infarction

Intervention: Human Serum Albumin 20 (Biological); 0.9 % Normal Saline (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Seoul St. Mary's Hospital

Official(s) and/or principal investigator(s):
Kwang Soo Lee, M.D, Ph.D, Principal Investigator, Affiliation: Seoul St. Mary's Hospital


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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Average change in NIHSS

Secondary outcome:


Proportion of patients with improvement by NIHSS

modified Rankin Scale(mRS) favorable outcome

Volume difference on diffusion MRI

Recurrent new ischemic lesions on diffusion MRI

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.


Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.


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


- 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 ≥


- Patients who received treatment of thrombolysis or who planned for treatment of


- 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.

Locations and Contacts

St. Vincent's hospital, Suwon, Gyeonggido, Korea, Republic of

Ewha Womans University Mokdong Hospital, Mok-dong, Seoul 158-710, Korea, Republic of

Seoul St. Mary's Hospital, Seocho-Gu, Seoul 137-701, Korea, Republic of

Yeoudo St. Mary's hospital, Yeongdeungpo-Gu, Seoul 150-713, Korea, Republic of

Additional Information

Starting date: September 2012
Last updated: November 28, 2013

Page last updated: August 23, 2015

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