NCT06629116 Study on the Role of Human Serum Albumin in Large Acute Ischemic Stroke of Anterior Circulation After Thrombectomy
| NCT ID | NCT06629116 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tingyu-Yi |
| Condition | Cerebral Ischemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-01-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2024-01-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Age 18-80 years old. 2. Acute ischemic stroke patients with NIHSS score ≥ 6. 3. Pre-stroke mRS (modified Rankin Scale) score ≤ 1. 4. 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. 5. 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. 6. 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. 7. Achieving vessel reperfusion of mTICI (modified Thrombolysis in Cerebral Infarction) grade 2b or 3 through mechanical thrombectomy. 8. Written informed consent signed by the patient or their legally authorized representative. Exclusion Criteria: 1. Intracranial hemorrhage confirmed by head CT or MRI. 2. Pre-stroke mRS score \> 2. 3. Severe allergy or absolute contraindication to iodine-based contrast agents. 4. Systolic blood pressure \> 185 mmHg or diastolic blood pressure \> 110 mmHg, and inability to control with antihypertensive medication. 5. Blood glucose \< 50 mg/dl (2.8 mmol/L) or \> 400 mg/dl (22.2 mmol/L) and difficult to correct. 6. Genetic or acquired bleeding diathesis, deficiency of coagulation factors, or oral anticoagulation with INR \> 1.7. 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. 8. Expected life expectancy \< 6 months. 9. Anticipated inability of the patient to complete the 90-day follow-up. 10. Suspected aortic dissection. 11. Brain tumors, intracranial aneurysms, or arteriovenous malformations with mass effect on imaging. 12. Neurological or psychiatric disorders affecting the assessment of the disease before the patient's stroke. 13. Pregnancy or reproductive-age women with positive urinary or serum β-human chorionic gonadotropin (HCG) test. 14. Currently participating in other clinical trials that may interfere with the results of this trial. 15. History of allergy to albumin. 16. Need for intermittent or long-term concomitant acute or chronic pulmonary diseases. 17. Congestive heart failure for any reason in the past 6 months or any condition requiring medication, hospitalization, etc., related to heart failure. 18. Symptomatic or diagnosed acute myocardial infarction, or occurrence of acute myocardial infarction within the past 6 months. 19. Other situations that the investigator believes are not suitable for participation or may pose significant risks to the patient.
Contact & Investigator
Tingyu Yi, Postgraduate
PRINCIPAL INVESTIGATOR
zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China
Frequently Asked Questions
Who can join the NCT06629116 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Cerebral Ischemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629116 currently recruiting?
Yes, NCT06629116 is actively recruiting participants. Contact the research team at siyuyufen@163.com for enrollment information.
Where is the NCT06629116 trial being conducted?
This trial is being conducted at Zhangzhou, China.
Who is sponsoring the NCT06629116 clinical trial?
NCT06629116 is sponsored by Tingyu-Yi. The principal investigator is Tingyu Yi, Postgraduate at zhangzhou Affiliated Hospital to Fujian Medical University , Fujian ,China. The trial plans to enroll 100 participants.