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.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 4
- 主要终点
- Average change in NIHSS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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 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.
研究组 & 干预措施
Human Serum Albumin 20
Human Serum Albumin 20% 100cc intravenously infused over 4~8h
干预措施: Human Serum Albumin 20 (Biological)
0.9 % Normal saline
Treatment with same volume of normal saline
干预措施: 0.9 % Normal Saline (Drug)
结局指标
主要结局
Average change in NIHSS
时间窗: at 14±3days
Comparison of the average change in NIHSS between the control and ALbumin group at screening(-12h\~0days) and 14±3days
次要结局
- Proportion of patients with improvement by NIHSS(at 14±3days)
- Recurrent new ischemic lesions on diffusion MRI(at 4±1days)
- NIHSS Score(at 14±3days)
- modified Rankin Scale(mRS) favorable outcome(at 3 months)
- Volume difference on diffusion MRI(at 4 days±1days)
研究者
Kwang Soo Lee
Neurology Professor
Seoul St. Mary's Hospital