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Tests albumin after clot removal in large strokes

Tests albumin infusion after clot removal in adults with large strokes.

Key facts

Who runs it
Tingyu-Yi
Where
Zhangzhou, ChinaSee the site
Trial code
Registry title
Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
Status
Recruiting
People taking part
100 people, planned
Started
30 Jan 2024
Expected to end
30 May 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments 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).
Record updated
8 October 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18-80 who had a large stroke on the front side of the brain and whose blocked vessel was reopened by thrombectomy. It tests human albumin given after the procedure.

Age
18 to 80 years
Sex
All sexes
Disease stage
Acute ischemic stroke with NIHSS score ≥ 6, within 24 hours of onset, caused by a blocked large vessel in the front of the brain (internal carotid artery or M1 or M2 segment of the middle cerebral artery). The large early stroke area on scans must be ASPECTS 3-6, or core infarct volume 50-100 ml on perfusion imaging.
Earlier treatment
Must have had mechanical thrombectomy with the vessel reopened to mTICI grade 2b or 3. Before the stroke, mRS score must be ≤ 1.

Main reasons for not taking part

  • Bleeding in the brain on CT or MRI
  • Severe kidney problems, or need for dialysis
  • Heart failure or heart attack in the past 6 months
  • Allergy to albumin
  • Pregnancy, or a positive pregnancy test in women who can have children

The registry criteria, word for word

Show all 27 criteriaShow less

Who can take part

  • 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 take part

  • Systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg, and inability to control with antihypertensive medication
  • Need for intermittent or long-term concomitant acute or chronic pulmonary diseases
  • Intracranial hemorrhage confirmed by head CT or MRI
  • Pre-stroke mRS score > 2
  • Severe allergy or absolute contraindication to iodine-based contrast agents
  • Neurological or psychiatric disorders affecting the assessment of the disease before the patient's stroke
  • 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
  • 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
  • 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
  • Pregnancy or reproductive-age women with positive urinary or serum β-human chorionic gonadotropin (HCG) test
  • History of allergy to albumin
  • 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
  • Currently participating in other clinical trials that may interfere with the results of this trial
  • Other situations that the investigator believes are not suitable for participation or may pose significant risks to the patient

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 80 years old?

Where in China

  • Zhangzhou Municipal HospitalZhangzhou, ChinaContact: Tingyu Yi, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Albumin groupTreatment 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).

    Treatment: 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 groupNo study treatment, for comparison

    Follow the current guidelines for standard conventional treatment.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests albumin after clot removal in large strokesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06629116, who can take part
Record updated
8 October 2024