An interventional study of Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes). in Cerebral Ischemia, sponsored by Tingyu-Yi. Recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-08.
Sponsored by Tingyu-Yi · Not applicable, Interventional, and Treatment
This project intends to explore the therapeutic efficacy of human serum albumin in mitigating postoperative cerebral edema and enhancing clinical outcomes following mechanical thrombectomy in patients with acute anterior circulation large-core ischemic stroke.
Human serum albumin is an important biological molecule that plays a critical role in maintaining intracellular osmotic pressure, combating oxidative stress, and suppressing inflammatory responses. Studies have indicated that serum albumin levels gradually decrease in acute-phase stroke patients, accompanied by increased blood-brain barrier disruption. Low albumin levels may exacerbate the progression of cerebral infarction. Furthermore, another study found a correlation between serum albumin levels and the prognosis of AIS. Research has confirmed that human serum albumin may have potential benefits in neuroprotection through mechanisms such as improving microcirculation, reducing oxidative stress, and inhibiting inflammatory responses.
In an experimental animal study of ischemic stroke, researchers discovered that in the middle cerebral artery occlusion (MCAO) model, rats treated with albumin showed significantly reduced neurological function scores and infarct volume compared to the saline group. The mechanism behind this effect may be related to albumin's ability to improve ischemic penumbral blood flow and enhance perfusion in occluded vessels' distal regions. Multiple preclinical studies have suggested that using albumin therapy after vascular recanalization can significantly reduce infarct volume, alleviate brain edema, and improve neurological function, highlighting the neuroprotective role of serum albumin. However, the clinical efficacy of serum albumin in ischemic stroke remains a subject of controversy.
The aim of this study is to investigate the role of human serum albumin in acute anterior circulation large core ischemic stroke after thrombectomy reperfusion, with the hope of providing new insights and methods for clinical treatment. This study will employ a prospective, multicenter, open-label, endpoint-blinded, randomized controlled research design to systematically evaluate the therapeutic effects of human serum albumin in acute anterior circulation large core ischemic stroke after thrombectomy reperfusion. Through clinical observation, imaging assessment, neurofunctional evaluation, and other methods, the investigators will delve into the intervention of human serum albumin in reperfusion injury and its mechanisms in neuroprotection. This research is expected to offer new perspectives and methods for the treatment of patients with acute anterior circulation large core ischemic stroke, provide scientific evidence for clinical practice, and contribute positively to improving patient outcomes and reducing the societal burden.
217 studies on the registry are indexed under Brain Ischemia; 42 are open to participants now.
This study's planned enrollment of 100 is above the median of 73 across 140 interventional studies indexed under Brain Ischemia.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).
Drug: Patients with AIS receive intravascular therapy, and within 10 minutes after the surgery, they are administered 100ml of 20% human albumin intravenously (infused within 30 minutes).
Follow the current guidelines for standard conventional treatment.
Drug page: Albumins
Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.
Also known as: Albumin
Functional independence Rate
mRS score of 0-2
Time frame: From enrollment to the end of treatment at 3 months
Rate of independent ambulation
modified Rankin Scale score of 0-3 scores
Time frame: From enrollment to the end of treatment at 3 months
sICH occurrence
New occurs Intracranial hemorrhage with NIHSS increase \>=4 points
Time frame: within 72 hours after enrollment
Plan to share: No — not sure
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Studies of the drug tested here: Albumins
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