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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy of Intra-arterial Albumin With Endovascular Treatment for Acute Ischemic Stroke : A Randomized, Controlled Pilot Study

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: intra-arterial infusion albumin
* Other: mechanical thrombectomy and a standard clinical therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intra-arterial group<br>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. | Drug: intra-arterial infusion albumin<br>* 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.<br>Other: mechanical thrombectomy and a standard clinical therapy<br>* mechanical thrombectomy and a standard clinical therapy<br>|
| Other: sham group<br>All participants have no intra-arterial albumin. | Other: mechanical thrombectomy and a standard clinical therapy<br>* mechanical thrombectomy and a standard clinical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral infarct volume | infarct volume is evaluated mainly through brain MRI | 24-48 hours after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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 | 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) | 24 ± 6 hours after randomization | 
| Barthel index (BI) | the BI is an ordinal disability score of 10 categories (range from 0-100, higher values indicate better prognosis) | 90 ±10 days after randomization | 
| revascularization on follow-up imaging | secondary imaging efficacy endpoint | 24 (16 to 36) hours | 
| 24-hours neurologic deterioration | NIHSS score increased by more than 4 points; the NIHSS is a stroke severity score composed of 11 items (range from 0 to 42, higher values indicate more severe deficits); clinical safety endpoint | 24 ± 6 hours after randomization | 
| any intracranial hemorrhage on follow-up imaging | imaging safety endpoints; per ECASSIII definition and per Heidelberg bleeding classification | 24 (12 to 36) hours | 
| symptomatic intracerebral hemorrhage | imaging safety endpoints; deterioration in NIHSS score of ≥4 point within 24 hours;per ECASS III definition and per Heidelberg bleeding classification | 24 (12 to 36) hours | 
| Mortality | clinical safety endpoint | 90 ± 10 days after randomization | 
| Stroke recurrence | clinical safety endpoint | 90 ± 10 days after randomization | 
| Survival rates | secondary clinical efficacy endpoint | 7 ± 2 days, 90 ± 10 days after randomization | 
| mRS4-6 | secondary clinical efficacy endpoint;the mRs is an ordinal disability score of 7 categories (0 = no symptoms to 5 = severe disability, and 6 = death) | 90 ± 10 days after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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albumin, acute ischemic stroke, intra-arterial, thrombectomy, neuroprotection