Tests albumin after clot removal in large strokes

Trial details

Who runs it

Tingyu-Yi

Trial code

NCT06629116

Record updated

8 October 2024

Original description

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 full original descriptionShow less

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.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT06629116