The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- cerebral infarct volume
研究概览
简要总结
Stroke is an acute focal injury of the central nervous system caused by cerebral vessels. One in every four people is affected by stroke at different times in life. Globally, stroke is the second leading cause of death and third leading cause of disability in adults. we hypothesized that in patients with acute large vessel occlusive ischemic stroke treated with mechanical thrombectomy, the infusion of 20% human serum albumin solution into the revascularization area can exert a stronger neuroprotective effect.
详细描述
In the previous period, we have conducted a clinical trial on the safety and feasibility of arterial infusion of 20% human serum albumin solution. The results of the study found that after arterial infusion of 20% human serum albumin solution at a dose of 0.6g/kg to the subject's vascularization area, the subjects did not develop significant complications related to albumin solution. There were no serious adverse events associated with arterial infusion of albumin solution in all subjects. After the evaluation of the Data Safety Monitoring Board, the clinical study was considered to be the next step, which is to initially explore the effectiveness of 0.6g/kg arterial infusion of 20% human serum albumin solution for neuroprotection of subjects.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Male or female, age≥18 and ≤ 80;
- •anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA;
- •baseline National Institute of Health Stroke Scale (NIHSS) score ≥6；
- •Alberta Stroke Program Early CT Score (ASPECTS) 6-10;
- •Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours；
- •occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；
- •Informed consent obtained;
排除标准
- •(1) history of congestive heart failure or jugular dilatation, third heart sound, resting tachycardia due to heart failure (>100 beats/min), hepatomegaly and lower limb edema without obvious cause on admission physical examination; (2) hospitalization for acute myocardial infarction within 3 months; (3) symptoms of acute myocardial infarction or admission electrocardiogram; (4) second or third degree heart block or arrhythmia with hemodynamic instability; (5) acute or chronic renal failure (blood creatinine > 2.0 mg/dL); (6) severe anemia (hematocrit<32%); (7) symptoms or CT evidence of subarachnoid hemorrhage; (8) pregnancy; (9) allergy to albumin; (10) admission blood pressure higher than 185/110 mmHg; (11) any chronic lung disease, including chronic obstructive pulmonary disease, bronchiectasis, and other lung diseases that interfere with daily activities; (12) presence of other diseases that may endanger life.
研究组 & 干预措施
sham group
All participants have no intra-arterial albumin.
干预措施: mechanical thrombectomy and a standard clinical therapy (Other)
intra-arterial group
20% human serum albumin (0.6g/kg) solution will be injected into the artery after revascularization in acute ischemic stroke. All participants will receive mechanical thrombectomy and a standard clinical therapy.
干预措施: intra-arterial infusion albumin (Drug)
intra-arterial group
20% human serum albumin (0.6g/kg) solution will be injected into the artery after revascularization in acute ischemic stroke. All participants will receive mechanical thrombectomy and a standard clinical therapy.
干预措施: mechanical thrombectomy and a standard clinical therapy (Other)
结局指标
主要结局
cerebral infarct volume
时间窗: 24-48 hours after randomization
infarct volume is evaluated mainly through brain MRI
次要结局
- scores assessed by National Institutes of Health Stroke Scale (NIHSS)(24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization)
- modified Rankin Scale score(mRS)(90 ±10 days after randomization)
- any intracranial hemorrhage on follow-up imaging(24 (12 to 36) hours)
- symptomatic intracerebral hemorrhage(24 (12 to 36) hours)
- the good prognosis at 90 days assessed by mRS(90 ±10 days after randomization)
- improvement of neurologic function after 24 hours(24 ± 6 hours after randomization)
- Barthel index (BI)(90 ±10 days after randomization)
- mRS4-6(90 ± 10 days after randomization)
- change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours(from baseline to 24 ± 6 hours)
- revascularization on follow-up imaging(24 (16 to 36) hours)
- 24-hours neurologic deterioration(24 ± 6 hours after randomization)
- Mortality(90 ± 10 days after randomization)
- Survival rates(7 ± 2 days, 90 ± 10 days after randomization)
- Stroke recurrence(90 ± 10 days after randomization)
研究者
Ming Wei
Chief physician
Tianjin Huanhu Hospital