Albumin for Patients With Acute Large Vessel Occlusive Stroke Undergoing Endovascular Reperfusion Therapy
NCT Number: NCT06538844
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Acute Ischemic Stroke
Interventions: DRUG: Intravenous infusion of human albumin|DRUG: Saline
Sponsor: Capital Medical University
Collaborators: Xuanwu Hospital, Beijing
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 134
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-03
Completion Date: 2025-07-31
Locations: Maanshan People's Hospital, Ma'anshan, Anhui, China|Suzhou Municipal Hospital of Anhui Province, Suzhou, Anhui, China|Luoyang Central Hospital Affiliated to Zhengzhou University, Luoyang, Henan, China|Nanyang Central Hospital, Nanyang, Henan, China|First People's Hospital of Zhengzhou City, Zhengzhou, Henan, China|Xihua County People's Hospital, Zhoukou, Henan, China|Northern Jiangsu People's Hospita!, Yangzhou, Jiangsu, China|Liaocheng Third People's Hospital, Liaocheng, Shandong, China

Summary:
The objective of this study is to evaluate the effectiveness and safety of endovascular therapy combined with 25% human albumin in the treatment of acute large vessel occlusive stroke.

Primary Outcome Measures: Changes in infarction volume from Day 5 to baseline., From 5 days after surgery to baseline
Secondary Outcome Measures: Early neurological improvement within 24 hours, Decrease in National Institute of Health stroke scale (NIHSS) score of ≥8 or NIHSS score of 0-2 within 24 hours. NIHSS scores range from 0 to 42, with higher scores indicating greater neurologic deficit, within 24 hours|NIHSS score at 24 hours, National Institutes of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating greater neurologic deficit, at 24 hours|Proportion of successful reperfusion (mTICI 2b/3), mTICI denotes modified Treatment in Cerebral Ischemia classification, with scores ranging from 0 (no flow) to 3 (normal flow), immediate postoperative|NIHSS score at 5 days, National Institutes of Health Stroke Scale (NIHSS), at 5 days|Proportion of patients with functional independence (mRS 0-1) at 90 days, Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability, at 90 days|Proportion of patients with functional independence (mRS 0-2) at 90 days, Scores on the modified Rankin scale range from 0 to 6, with higher scores indicating greater disability, at 90 days|Proportion of patients with Barthel Index of 95-100 at 90 days, at 90 days|European quality of Life-5 Dimensions (EQ-5D) at 90 days, at 90 days|Symptomatic intracerebral hemorrhage (ICH) Within 24 Hours, within 24 hours|Intracerebral hemorrhage within 24 Hours, within 24 hours|Neurological deterioration within 24 hours, NIHSS score increased by ≥4 points within 24 hours., within 24 hours|New-onset atrial fibrillation within 5 days, within 5 days|Pulmonary edema or congestive heart failure within 5 days, within 5 days|Intracerebral hemorrhage within 5 days, within 5 days|Symptomatic intracerebral hemorrhage (ICH) Within 5 days, within 5 days|Decompressive craniectomy within 7 days, within 7 days|Death within 90 days, within 90 days|Number of participants who experience adverse events (AEs), within 90 days|Number of participants who experience serious adverse events (SAEs), within 90 days