Acute Ischemic Stroke From Large Vessel Occlusion
Conditions
Keywords
Acute ischemic stroke, large vessel occlusion, mechanical thrombectomy, albumin, neuroprotection
Brief summary
Albumin-assisted therapy has demonstrated good safety and potential neuroprotective effects following mechanical thrombectomy. To further systematically evaluate its efficacy and safety, we are conducting a Phase IIa clinical trial of intra-arterial albumin administration combined with mechanical thrombectomy in patients with acute ischemic stroke. This is a double-center, prospective, open-label, endpoint-blinded, randomized controlled trial designed to preliminarily assess the efficacy and safety of intra-arterial infusion of 20% human albumin after successful recanalization in patients with acute ischemic stroke caused by anterior circulation large-vessel occlusion who undergo mechanical thrombectomy. A total of 60 patients will be enrolled and randomized in a 1:1 ratio by dynamic minimization into two groups: the albumin group (0.6 g/kg of 20% human albumin solution plus mechanical thrombectomy) and the control group (mechanical thrombectomy alone). The primary objective of this study is to preliminarily evaluate whether intra-arterial infusion of 0.6 g/kg of 20% human albumin via the internal carotid artery immediately after achieving successful recanalization (eTICI ≥ 2b) can reduce infarct volume compared with mechanical thrombectomy alone in patients with anterior circulation large-vessel occlusion who undergo standard mechanical thrombectomy. The secondary objective is to assess the safety and feasibility of intra-arterial infusion of 0.6 g/kg of 20% human albumin immediately after successful recanalization in this patient population.
Interventions
20% human albumin solution at a dose of 0.60 g/kg will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes.
Sponsors
The First Hospital of Qinhuangdao
Tianjin Huanhu Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
independent Imaging Core Laboratory
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1.Age ≥ 18 years; 2.ICA or MCA-M1 occlusion, confirmed by preoperative CTA/MRA/DSA. ICA occlusion can be cervical or intracranial, with or without tandem MCA lesions; Treated with EVT resulting in recanalization ((expanded Thrombolysis in Cerebral Infarction \[eTICI\] 2b-3); 3.Baseline NIHSS scores ≥ 6; 4.Baseline ASPECTS ≥6 on non-contrast CT; 5.The time from stroke onset/last seen well to arterial puncture is within 24 hours; 6.No significant pre-stroke disability (pre-stroke mRS ≤2); 7.Signed informed consent from the patient or the legally authorized representative
Exclusion criteria
* 1.Presence of intracranial hemorrhage on head CT or MRI； 2.Midline shift with significant mass effect on head CT or MRI； 3.History of heart failure or severe cardiovascular disease, including but not limited to pulmonary hypertension, pericardial effusion, etc； 4.Arrhythmia accompanied by hemodynamic instability； 5.Symptoms or electrocardiographic evidence of acute myocardial infarction upon admission； 6.Acute or chronic renal failure (serum creatinine \>2.0 mg/dL)； 7.Severe anemia (hematocrit \<32%)； 8.Known allergy to albumin or blood products； 9.Pregnant women； 10.Persistent blood pressure ≥180/100 mmHg prior to albumin infusion； 11.Concurrent participation in another clinical trial； 12.Life expectancy of less than 3 months； 13.Coexisting severe pulmonary diseases such as Chronic Obstructive Pulmonary Disease, pulmonary fibrosis, pleural effusion, pulmonary hypertension, or acute respiratory distress syndrome； 14.Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth in infarct volume at 24 (±6) hours after randomization compared to baseline | at 24 (±6) hours after randomization | MRI-DWI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2 | at 90 (±14) day after randomizatio | mRS |
| Infarct volume at 24 (±6) hours | at 24 (±6) hours after randomization | MRI-DWI |
| mRS score at 90 (±14) days | at 90 (±14) days after randomization | mRS |
| Vessel recanalization at 24 (±6) hours | at 24 (±6) hours after randomization | CTA or MRA or DSA |
| NIHSS score at 24 (±6) hours | at 24 (±6) hours after randomization | NIHSS |
| NIHSS score at 7 (±1) days/at discharge | at 7 (±1) days/at discharge after randomization | NIHSS |
| EQ-5D-5L at 90 (±14) days | at 90 (±14) days after randomization | EQ-5D-5L |
| Proportion of Barthel Index ≥95 at 90 (±14) days | at 90 (±14) days after randomization | Barthel Index |
| Incidence of all-cause death within 90 (±14) days | at 90 (±14) days after randomization | all-cause death |
| Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1 | at 90 (±14) day after randomization | mRS |
| Incidence of intracranial hemorrhage within 24 (±6) hours | at 24 (±6) hours after randomization | all-cause |
| Incidence of serious adverse events within 90 (±14) days | at 90 (±14) days after randomization | serious adverse events |
| Incidence of adverse events within 90 (±14) days | at 90 (±14) days after randomization | adverse events |
| Proportion of early neurological deterioration at 24 hours | at 24 hours after randomization | defined as ≥ 4-point increase in NIHSS score from baseline |
| Proportion of severe disability at 90 (±14) days | at 90 (±14) days after randomization | defined as mRS 4-6 |
| Incidence of albumin infusion-associated adverse event within 24 (± 6) hours | at 24 (± 6) hours after randomization | albumin infusion-associated adverse event |
| Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours | at 24 (±6) hours after randomization | according to the modified Heidelberg Bleeding Classification |
Other
| Measure | Time frame | Description |
|---|---|---|
| Blood levels of albumin and BNP at 7 (±1) days after randomization or at discharge (whichever occurs first) | at 7 (±1) days after randomization or at discharge (whichever occurs first) | albumin and BNP |
| The along the perivascular space (ALPS) index at 24 (±6) hours after randomization | at 24 (±6) hours after randomization | along the perivascular space index |
| Blood levels of albumin and BNP at 24 (±6) hours after randomization | at 24 (±6) hours after randomization | albumin and BNP |
Contacts
Primary ContactMing Wei PhD, PhD
Backup ContactDu, PhD
Outcome results
None listed