Actively Recruiting
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
Led by Tingyu-Yi · Updated on 2024-10-08
100
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the potential benefits of human serum albumin in reducing brain swelling and improving recovery after mechanical thrombectomy in patients who have suffered an acute anterior circulation large-core ischemic stroke. This study aims to provide new insights and treatment methods by systematically investigating the effects of albumin in this specific stroke population. The trial uses a prospective, multicenter, open-label, endpoint-blinded, randomized controlled design to explore these possibilities. Participants will be randomly assigned to receive either an intravenous infusion of 100 ml of 20% human serum albumin within 10 minutes after thrombectomy surgery, infused over 30 minutes, or standard conventional treatment following current guidelines. The study compares the albumin treatment group to a control group receiving no albumin intervention. This design allows researchers to observe differences in clinical outcomes and brain recovery processes between the two groups. During the study, participants will undergo clinical observations, imaging assessments, and evaluations of neurological function to measure the effects of the treatments. The primary outcome is the rate of functional independence at 3 months post-treatment. Secondary outcomes include the rate of independent walking at 3 months. Safety monitoring and follow-up evaluations will continue for the duration of the study, with total participation extending up to three months from enrollment.
CONDITIONS
Brief Title
Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years old
- Acute ischemic stroke with NIHSS score 6 or higher
- Pre-stroke modified Rankin Scale (mRS) score of 1 or less
- Symptom onset to presentation within 24 hours, including wake-up or unwitnessed strokes
- Confirmed anterior circulation large vessel occlusion stroke (internal carotid artery or M1/M2 segments of middle cerebral artery)
- ASPECTS score on non-contrast CT of 3 to 6 or core infarct volume of 50-100 ml on cerebral perfusion imaging
- Achieved vessel reperfusion grade 2b or 3 after mechanical thrombectomy
- Signed informed consent by patient or legal representative
You will not qualify if you...
- Intracranial hemorrhage detected by CT or MRI
- Pre-stroke mRS score greater than 2
- Severe allergy or contraindication to iodine contrast agents
- Uncontrolled high blood pressure (systolic >185 mmHg or diastolic >110 mmHg)
- Blood glucose below 50 mg/dl or above 400 mg/dl and not correctable
- Bleeding disorders or anticoagulation with INR above 1.7
- Severe kidney dysfunction or need for dialysis
- Life expectancy less than 6 months
- Inability to complete 90-day follow-up
- Suspected aortic dissection
- Brain tumors, aneurysms, or vascular malformations with mass effect
- Neurological or psychiatric disorders affecting stroke assessment
- Pregnancy or positive pregnancy test
- Participation in other interfering clinical trials
- Allergy to albumin
- Chronic or acute pulmonary diseases requiring treatment
- Recent congestive heart failure or related conditions
- Recent or symptomatic acute myocardial infarction
- Other conditions deemed unsuitable or risky by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months from enrollment
Participants receive intravascular therapy including mechanical thrombectomy, followed by administration of human serum albumin or standard treatment according to randomization.
Initial treatment visit plus follow-up visits over 3 months
Trial Site Locations
Total: 1 location
1
Zhangzhou Municipal Hospital
Zhangzhou, Fujian, China, 363000
Actively Recruiting
Research Team
T
Tingyu Yi, Postgraduate
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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