A Phase 2 interventional study of Human serum albumin infusion 20% in Acute Ischemic Stroke From Large Vessel Occlusion, sponsored by Tianjin Huanhu Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Tianjin Huanhu Hospital · Phase 2, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Tianjin Huanhu Hospital is the lead sponsor of 25 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects assigned to the albumin treatment group after achieving successful recanalization (eTICI ≥ 2b) confirmed by DSA post-thrombectomy will receive a 20% human albumin solution at a dose of 0.60 g/kg. The solution will be administered as a constant-rate infusion into the proximal internal carotid artery over 20 minutes. Vital signs and potential infusion-related reactions must be closely monitored throughout the procedure.
Drug: Human serum albumin infusion 20%
Subjects in the control group who have achieved successful recanalization (eTICI ≥ 2b) as confirmed by DSA following mechanical thrombectomy will not receive the investigational infusion and will undergo standard medical management only.
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.
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline
MRI-DWI
Time frame: at 24 (±6) hours after randomization
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
Blood levels of albumin and BNP at 24 (±6) hours after randomization
albumin and BNP
Time frame: at 24 (±6) hours after randomization
Blood levels of albumin and BNP at 7 (±1) days after randomization or at discharge (whichever occurs first)
albumin and BNP
Time frame: at 7 (±1) days after randomization or at discharge (whichever occurs first)
The along the perivascular space (ALPS) index at 24 (±6) hours after randomization
along the perivascular space index
Time frame: at 24 (±6) hours after randomization
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
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Tianjin Huanhu Hospital