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

Phase 2

Terminated

• Conditions: Cerebral Infarction
• Interventions: Drug: 0.9 % Normal Saline; Biological: Human Serum Albumin 20

• Registration Number: NCT01684462
• Lead Sponsor: Seoul St. Mary's Hospital

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.

Study Timeline

• Study First Submitted: 2012-08-21
• Study Start: 2012-09
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-13
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-28
• Last Update Posted: 2013-12-02
• Primary Completion: 2014-09
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9 % Normal saline	0.9 % Normal Saline	Treatment with same volume of normal saline
Human Serum Albumin 20	Human Serum Albumin 20	Human Serum Albumin 20% 100cc intravenously infused over 4\~8h

Primary Outcome Measures

Name	Time	Method
Average change in NIHSS	at 14±3days	Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h\~0days) and 14±3days

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with improvement by NIHSS	at 14±3days	Comparison of the proportion of patients with improvement in NIHSS over 4 at 14±3days.
Recurrent new ischemic lesions on diffusion MRI	at 4±1days	Comparison of the proportion of patients who appear to be recurrent new ischemic lesions defined by diffusion MRI
NIHSS Score	at 14±3days	Comparison of NIHSS score between the control and ALbumin group at 14±3days
modified Rankin Scale(mRS) favorable outcome	at 3 months	Comparison of the global functional outcome on modified Rankin Scale(mRS) at screening(-12h\~0days) and 3 months.
Volume difference on diffusion MRI	at 4 days±1days	Comparison of the volume difference of cerebral infraction defined by diffusion MRI at 4±1days

Trial Locations

Locations (4)

Ewha Womans University Mokdong Hospital; 🇰🇷 Mok-dong, Seoul, Korea, Republic of

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

Seoul St. Mary's Hospital; 🇰🇷 Seocho-Gu, Seoul, Korea, Republic of

Yeoudo St. Mary's hospital; 🇰🇷 Yeongdeungpo-Gu, Seoul, Korea, Republic of