Acute Ischemic Stroke From Large Vessel OcclusionPhase 2NCT07294391
The Preliminary Efficacy and Safety of Intra-Arterial Albumin as Adjunct to Mechanical Thrombectomy in Acute Ischemic Stroke
A Phase 2 study testing Human serum albumin infusion 20% in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Tianjin Huanhu Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke From Large Vessel Occlusion
- What is being tested?
- Human serum albumin infusion 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2025to 1 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Du, PhD contact
About this study
Official title: 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
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.
- Being tested
- Human serum albumin infusion 20%
- Keywords
- Acute ischemic stroke, large vessel occlusion, mechanical thrombectomy, albumin, neuroprotection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human serum albumin infusion 20%Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Albumin Group | Experimental | 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. Receives: Drug: Human serum albumin infusion 20% |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline
MRI-DWI
Measured: at 24 (±6) hours after randomization
Secondary outcomes (17)
Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2
mRS
Measured: at 90 (±14) day after randomizatio
Infarct volume at 24 (±6) hours
MRI-DWI
Measured: at 24 (±6) hours after randomization
Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1
mRS
Measured: at 90 (±14) day after randomization
mRS score at 90 (±14) days
mRS
Measured: at 90 (±14) days after randomization
Vessel recanalization at 24 (±6) hours
CTA or MRA or DSA
Measured: at 24 (±6) hours after randomization
NIHSS score at 24 (±6) hours
NIHSS
Measured: at 24 (±6) hours after randomization
NIHSS score at 7 (±1) days/at discharge
NIHSS
Measured: at 7 (±1) days/at discharge after randomization
EQ-5D-5L at 90 (±14) days
EQ-5D-5L
Measured: at 90 (±14) days after randomization
Proportion of Barthel Index ≥95 at 90 (±14) days
Barthel Index
Measured: at 90 (±14) days after randomization
Incidence of all-cause death within 90 (±14) days
all-cause death
Measured: at 90 (±14) days after randomization
Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours
according to the modified Heidelberg Bleeding Classification
Measured: at 24 (±6) hours after randomization
Incidence of intracranial hemorrhage within 24 (±6) hours
all-cause
Measured: at 24 (±6) hours after randomization
Incidence of serious adverse events within 90 (±14) days
serious adverse events
Measured: at 90 (±14) days after randomization
Incidence of adverse events within 90 (±14) days
adverse events
Measured: at 90 (±14) days after randomization
Proportion of early neurological deterioration at 24 hours
defined as ≥ 4-point increase in NIHSS score from baseline
Measured: at 24 hours after randomization
Proportion of severe disability at 90 (±14) days
defined as mRS 4-6
Measured: at 90 (±14) days after randomization
Incidence of albumin infusion-associated adverse event within 24 (± 6) hours
albumin infusion-associated adverse event
Measured: at 24 (± 6) hours after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start10 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic Stroke From Large Vessel OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Huanhu Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Hospital of Qinhuangdao
- Responsible party
- Principal investigator, Ming Wei, Tianjin Huanhu Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07294391
- Sponsor's protocol ID
- TJHH_WM_20251125
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07294391
- Acronym / sponsor ID
- TJHH_WM_20251125
- Keywords
- Acute ischemic stroke, large vessel occlusion, mechanical thrombectomy, albumin, neuroprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Tianjin Huanhu HospitalUniversity, hospital or other
- Collaborators
- The First Hospital of Qinhuangdao
- Study start
- 10 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin Group | Experimental | Drug: Human serum albumin infusion 20%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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human serum albumin infusion 20%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. | Drug | Albumin Group |
Primary outcome
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline
Time frame: at 24 (±6) hours after randomization
MRI-DWI
17 secondary outcomes
Proportion of favorable functional outcome at 90 (±14) days, defined as mRS 0-2
Time frame: at 90 (±14) day after randomizatio
Infarct volume at 24 (±6) hours
Time frame: at 24 (±6) hours after randomization
Proportion of excellent functional at 90 (±14) days, defined as mRS 0-1
Time frame: at 90 (±14) day after randomization
mRS score at 90 (±14) days
Time frame: at 90 (±14) days after randomization
Vessel recanalization at 24 (±6) hours
Time frame: at 24 (±6) hours after randomization
NIHSS score at 24 (±6) hours
Time frame: at 24 (±6) hours after randomization
NIHSS score at 7 (±1) days/at discharge
Time frame: at 7 (±1) days/at discharge after randomization
EQ-5D-5L at 90 (±14) days
Time frame: at 90 (±14) days after randomization
Proportion of Barthel Index ≥95 at 90 (±14) days
Time frame: at 90 (±14) days after randomization
Incidence of all-cause death within 90 (±14) days
Time frame: at 90 (±14) days after randomization
Incidence of symptomatic intracranial hemorrhage within 24 (±6) hours
Time frame: at 24 (±6) hours after randomization
Incidence of intracranial hemorrhage within 24 (±6) hours
Time frame: at 24 (±6) hours after randomization
Incidence of serious adverse events within 90 (±14) days
Time frame: at 90 (±14) days after randomization
Incidence of adverse events within 90 (±14) days
Time frame: at 90 (±14) days after randomization
Proportion of early neurological deterioration at 24 hours
Time frame: at 24 hours after randomization
Proportion of severe disability at 90 (±14) days
Time frame: at 90 (±14) days after randomization
Incidence of albumin infusion-associated adverse event within 24 (± 6) hours
Time frame: at 24 (± 6) hours after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Du, PhD contact
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Human serum albumin infusion 20% in people with Acute Ischemic Stroke From Large Vessel Occlusion, run by Tianjin Huanhu Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming Wei PhD, PhD (86+13502182903, weiming@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth in infarct volume at 24 (±6) hours after randomization compared to baseline (time frame: at 24 (±6) hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.