Human serum albumin infusion 20%
Drug20% 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.
NCT Number: NCT07294391
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 2
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: at 24 (±6) hours after randomization
MRI-DWI
Time frame: at 90 (±14) day after randomizatio
mRS
Time frame: at 24 (±6) hours after randomization
MRI-DWI
Time frame: at 90 (±14) day after randomization
mRS
Time frame: at 90 (±14) days after randomization
mRS
Time frame: at 24 (±6) hours after randomization
CTA or MRA or DSA
Time frame: at 24 (±6) hours after randomization
NIHSS
Time frame: at 7 (±1) days/at discharge after randomization
NIHSS
Time frame: at 90 (±14) days after randomization
EQ-5D-5L
Time frame: at 90 (±14) days after randomization
Barthel Index
Time frame: at 90 (±14) days after randomization
all-cause death
Time frame: at 24 (±6) hours after randomization
according to the modified Heidelberg Bleeding Classification
Time frame: at 24 (±6) hours after randomization
all-cause
Time frame: at 90 (±14) days after randomization
serious adverse events
Time frame: at 90 (±14) days after randomization
adverse events
Time frame: at 24 hours after randomization
defined as ≥ 4-point increase in NIHSS score from baseline
Time frame: at 90 (±14) days after randomization
defined as mRS 4-6
Time frame: at 24 (± 6) hours after randomization
albumin infusion-associated adverse event
Time frame: at 24 (±6) hours after randomization
albumin and BNP
Time frame: at 7 (±1) days after randomization or at discharge (whichever occurs first)
albumin and BNP
Time frame: at 24 (±6) hours after randomization
along the perivascular space index
Contact information is provided by the study sponsor or research team.
Tianjin Huanhu Hospital
Other
The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke:Dual-Center, Prospective, Open-Label, Endpoint-Blinded, Randomized Controlled Clinical Trial
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