Intra-arterial Albumin in Acute Ischemic Stroke After Endovascular Treatment for

Tianjin Huanhu Hospital46 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

intra-arterial infusion albuminDRUG

The experimental group would inject 20% human blood albumin solution into the responsible blood vessel supply area by catheter artery at a dose of 0.6g/kg. The infusion time is 20-30 minutes. All participant will receive mechanical thrombectomy and a standard clinical therapy.

mechanical thrombectomy and a standard clinical therapyOTHER

mechanical thrombectomy and a standard clinical therapy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1.Male or female, age≥18 and ≤ 80; 2. anterior circulation large vessel occlusion confirmed by CTA, MRA and DSA; 3. baseline National Institute of Health Stroke Scale (NIHSS) score ≥6； 4. Alberta Stroke Program Early CT Score (ASPECTS) 6-10; 5. Stroke symptoms present to femoral artery or brachial artery puncture within 24 hours； 6. occluded vessel reaches eTICI level ≥2b after thrombectomy confirmed by DSA；7. Informed consent obtained; Exclusion Criteria: (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.

Locations (1)

Ming wei

Tianjin, China, Tianjin Municipality, China

Outcomes

Primary Outcomes

cerebral infarct volume

infarct volume is evaluated mainly through brain MRI

Time frame: 24-48 hours after randomization

Secondary Outcomes

modified Rankin Scale score(mRS)

the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

Time frame: 90 ±10 days after randomization

the good prognosis at 90 days assessed by mRS

the mRS is an ordinal disability score of 7 categories (0=no symptoms to 5=severe disability, and 6=death)

Time frame: 90 ±10 days after randomization

scores assessed by National Institutes of Health Stroke Scale (NIHSS)

the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits

Time frame: 24 ± 6 hours, 48 ± 12 hours, 7 ± 2 days, 90 ±10 days after randomization

change in National Institutes of Health Stroke Scale (NIHSS) score from baseline to 24 hours

the NIHSS is a stroke severity score that is composed of 11 items, range from 0 to 42, higher values indicate more severe deficits

Time frame: from baseline to 24 ± 6 hours

improvement of neurologic function after 24 hours

NIHSS score decreased by more than 4 points or NIHSS score was 0; secondary clinical efficacy endpoint; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severs deficits)

Time frame: 24 ± 6 hours after randomization

Barthel index (BI)

Data from ClinicalTrials.gov

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