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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhangzhou Municipal Hospital
RECRUITING
Zhangzhou
Contact Information
Primary
Tingyu Yi, Postgraduate
siyuyufen@163.com
+86-05962082582
Time Frame
Start Date: 2024-01-30
Estimated Completion Date: 2027-05-30
Participants
Target number of participants: 100
Treatments
Experimental: Albumin group
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).
No_intervention: Control group
Follow the current guidelines for standard conventional treatment.
Related Therapeutic Areas
Sponsors
Leads: Tingyu-Yi

This content was sourced from clinicaltrials.gov

Similar Clinical Trials