The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke

Phase 2Not Yet RecruitingNCT07294391

Tianjin Huanhu Hospital60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Growth in infarct volume at 24 (±6) hours after randomization compared to baseline

MRI-DWI

Time frame: at 24 (±6) hours after randomization

Secondary Outcomes

Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2

mRS

Time frame: at 90 (±14) day after randomizatio

Infarct volume at 24 (±6) hours

MRI-DWI

Time frame: at 24 (±6) hours after randomization

Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1

mRS

Time frame: at 90 (±14) day after randomization

mRS score at 90 (±14) days

mRS

Time frame: at 90 (±14) days after randomization

Vessel recanalization at 24 (±6) hours

CTA or MRA or DSA

Time frame: at 24 (±6) hours after randomization

NIHSS score at 24 (±6) hours

NIHSS

Time frame: at 24 (±6) hours after randomization

NIHSS score at 7 (±1) days/at discharge

NIHSS

Time frame: at 7 (±1) days/at discharge after randomization

EQ-5D-5L at 90 (±14) days

EQ-5D-5L

Time frame: at 90 (±14) days after randomization

Proportion of Barthel Index ≥95 at 90 (±14) days

Barthel Index

Time frame: at 90 (±14) days after randomization

Incidence of all-cause death within 90 (±14) days

all-cause death

Time frame: at 90 (±14) days after randomization

Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours

according to the modified Heidelberg Bleeding Classification

Time frame: at 24 (±6) hours after randomization

Incidence of intracranial hemorrhage within 24 (±6) hours

all-cause

Time frame: at 24 (±6) hours after randomization

Incidence of serious adverse events within 90 (±14) days

serious adverse events

Time frame: at 90 (±14) days after randomization

Incidence of adverse events within 90 (±14) days

adverse events

Time frame: at 90 (±14) days after randomization

Proportion of early neurological deterioration at 24 hours

defined as ≥ 4-point increase in NIHSS score from baseline

Time frame: at 24 hours after randomization

Proportion of severe disability at 90 (±14) days

defined as mRS 4-6

Time frame: at 90 (±14) days after randomization

Incidence of albumin infusion-associated adverse event within 24 (± 6) hours

albumin infusion-associated adverse event

Time frame: at 24 (± 6) hours after randomization

The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts