Clinical trial NCT01684462: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Cerebral Infarction
Keywords: Acute Ischemic Stroke
Albumin
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2012-09-13
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Average change in NIHSS
timeFrame: at 14±3days
Secondary outcomes:
measure: NIHSS Score
timeFrame: at 14±3days
measure: Proportion of patients with improvement by NIHSS
timeFrame: at 14±3days
measure: modified Rankin Scale(mRS) favorable outcome
timeFrame: at 3 months
measure: Volume difference on diffusion MRI
timeFrame: at 4 days±1days
measure: Recurrent new ischemic lesions on diffusion MRI
timeFrame: at 4±1days
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's hospital
state: Gyeonggido
city: Mok-dong
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
state: Seoul
city: Seocho-Gu
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Seoul
city: Yeongdeungpo-Gu
country: Korea, Republic of
facility: Yeoudo St. Mary's hospital
state: Seoul
Study officials:
affiliation: Seoul St. Mary's Hospital
name: Kwang Soo Lee, M.D, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: