About this trial
This study is a prospective, multicenter, open-label, randomized controlled clinical trial. The investigators will apply albumin to the reperfusion treatment of patients with acute ischemic stroke in the anterior circulation. This study aims to verify the efficacy and safety of albumin combined with endovascular treatment in patients with anterior circulation acute ischemic stroke.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 80 years;
Acute ischemic stroke with indications for endovascular treatment within 24 hours of onset;
Anterior circulation acute ischemic stroke, with acute occlusion of the responsible vessel located in the intracranial segment of the internal carotid artery, or the M1 or M2 segment of the middle cerebral artery;
National Institute of Health Stroke Scale (NIHSS) score >=6;
Disqualifiers
Evidence of intracranial hemorrhage (intracerebral hematoma (ICH), subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT or MRI scan;
History of congenital or acquired bleeding disorders, coagulation factor deficiency diseases, thrombocytopenic diseases, etc;
Anticipated difficulty in completing endovascular treatment due to vascular tortuosity;
Known severe allergy (more severe than skin rash) to contrast agents uncontrolled by medications;
Trial design
Parallel
Treatments tested in this trial
Albumin
Drug25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered intravenously. On the second, third, and fourth days, 25% human albumin at a dose of 0.5g/kg (maximum dose 37.5g) should be administered daily.
Endovascular treatment
Procedure/SurgeryBest endovascular treatment.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of patients with mRS 0-2 or return to baseline mRS (if the baseline premorbid mRS =3-4) at 90 days.
Scores on the modified Rankin scale range from 0 (no neurologic deficit) to 6 (death)
Secondary outcomes
Distribution of mRS scores
Proportion of patients with mRS score 0-1
24h National Institutes of Health Stroke Scale (NIHSS)
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
National Institutes of Health Stroke Scale (NIHSS) at 7 days
The NIHSS ranges from 0 to 42, with higher scores indicating worse outcomes.
Other outcomes
The incidence of symptomatic intracerebral hemorrhage
The incidence of newly onset atrial fibrillation within 7 days
The incidence rate of newly onset pulmonary edema or congestive heart failure within 7 days
All-cause mortality rate
Sponsors and contacts
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