Cerebral IschemiaNCT06629116
Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
A study testing 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 people with Cerebral Ischemia, run by Tingyu-Yi at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cerebral Ischemia
- What is being tested?
- 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).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jan 2024to 30 May 2027
- Phase
- Interventional
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years old.
- Acute ischemic stroke patients with NIHSS score ≥ 6.
- Pre-stroke mRS (modified Rankin Scale) score ≤ 1.
- Onset of symptoms to presentation within 24 hours, including wake-up strokes or strokes without witnessed onset; the time of symptom onset is defined as the "last seen normal" time.
- Confirmed by CTA/MRA/DSA to have anterior circulation large vessel occlusive ischemic stroke (occlusion of the internal carotid artery or M1 or M2 segments of the middle cerebral artery), responsible for acute ischemic stroke signs and symptoms.
- ASPECTS (Alberta Stroke Program Early CT Score) on NCCT (non-contrast CT) 3-6 or cerebral perfusion imaging: core infarct volume (rCBF ≤ 30%) 50-100 ml.
- Achieving vessel reperfusion of mTICI (modified Thrombolysis in Cerebral Infarction) grade 2b or 3 through mechanical thrombectomy.
- Written informed consent signed by the patient or their legally authorized representative.
Who cannot join
- Intracranial hemorrhage confirmed by head CT or MRI.
- Pre-stroke mRS score > 2.
- Severe allergy or absolute contraindication to iodine-based contrast agents.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and inability to control with antihypertensive medication.
- Blood glucose < 50 mg/dl (2.8 mmol/L) or > 400 mg/dl (22.2 mmol/L) and difficult to correct.
- Genetic or acquired bleeding diathesis, deficiency of coagulation factors, or oral anticoagulation with INR > 1.7.
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- Severe renal dysfunction defined as serum creatinine > 3.0 mg/dl (or 265.2 μmol/l) or glomerular filtration rate (GFR) < 30 ml/min, or need for hemodialysis or peritoneal dialysis.
- Expected life expectancy < 6 months.
- Anticipated inability of the patient to complete the 90-day follow-up.
- Suspected aortic dissection.
- Brain tumors, intracranial aneurysms, or arteriovenous malformations with mass effect on imaging.
- Neurological or psychiatric disorders affecting the assessment of the disease before the patient's stroke.
- Pregnancy or reproductive-age women with positive urinary or serum β-human chorionic gonadotropin (HCG) test.
- Currently participating in other clinical trials that may interfere with the results of this trial.
- History of allergy to albumin.
- Need for intermittent or long-term concomitant acute or chronic pulmonary diseases.
- Congestive heart failure for any reason in the past 6 months or any condition requiring medication, hospitalization, etc., related to heart failure.
- Symptomatic or diagnosed acute myocardial infarction, or occurrence of acute myocardial infarction within the past 6 months.
- Other situations that the investigator believes are not suitable for participation or may pose significant risks to the patient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, 363000
Tingyu Yi, MD, 15859635985, siyuyufen@163.com
About this study
Official title: Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy: A Prospective, Multicenter, Open-label, Endpoint-blinded, Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Cerebral Ischemia
- Being tested
- 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).
- Medical subject headings
- Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Also called Albumin
Whether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion.
| Study group | Role | What they receive |
|---|---|---|
| Albumin group | Experimental | 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). Receives: 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). |
| Control group | No intervention | Follow the current guidelines for standard conventional treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional independence Rate
mRS score of 0-2
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (1)
Rate of independent ambulation
modified Rankin Scale score of 0-3 scores
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start30 Jan 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral IschemiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tingyu-Yi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tingyu-Yi, Zhangzhou Municipal Hospital
- Investigators
- Tingyu Yi, Postgraduate, Principal investigator, zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629116
- Sponsor's protocol ID
- Human Serum Albumin
- Status last verified
- Oct 2024
- First submitted
- 5 Oct 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: not sure
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy: A Prospective, Multicenter, Open-label, Endpoint-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06629116
- Acronym / sponsor ID
- Human Serum Albumin
- Conditions
- Cerebral Ischemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tingyu-YiUniversity, hospital or other
- Study start
- 30 Jan 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 8 Oct 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin group | Experimental | 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).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). |
| Control group | No intervention | –Follow the current guidelines for standard conventional treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-80 years old.
- Acute ischemic stroke patients with NIHSS score ≥ 6.
- Pre-stroke mRS (modified Rankin Scale) score ≤ 1.
- Onset of symptoms to presentation within 24 hours, including wake-up strokes or strokes without witnessed onset; the time of symptom onset is defined as the "last seen normal" time.
- Confirmed by CTA/MRA/DSA to have anterior circulation large vessel occlusive ischemic stroke (occlusion of the internal carotid artery or M1 or M2 segments of the middle cerebral artery), responsible for acute ischemic stroke signs and symptoms.
Key exclusion criteria (19 listed)
- Intracranial hemorrhage confirmed by head CT or MRI.
- Pre-stroke mRS score > 2.
- Severe allergy or absolute contraindication to iodine-based contrast agents.
- Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and inability to control with antihypertensive medication.
- Blood glucose < 50 mg/dl (2.8 mmol/L) or > 400 mg/dl (22.2 mmol/L) and difficult to correct.
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 |
|---|---|---|
| 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).Also: AlbuminWhether to administer albumin to AIS patients after intravascular thrombectomy and reperfusion. | Drug | Albumin group |
Primary outcome
Functional independence Rate
Time frame: From enrollment to the end of treatment at 3 months
mRS score of 0-2
1 secondary outcome
Rate of independent ambulation
Time frame: From enrollment to the end of treatment at 3 months
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 8 Oct 2024.
- Individual participant dataSharing planned: No. not sure
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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.
Tingyu Yi, Postgraduate principal investigator
zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 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 people with Cerebral Ischemia, run by Tingyu-Yi at 1 site in China.
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 8 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Tingyu Yi, Postgraduate (+86-05962082582, siyuyufen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional independence Rate (time frame: From enrollment to the end of treatment at 3 months). 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 8 Oct 2024.