Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
- Conditions
- Ischemic Stroke
- Registration Number
- NCT04708730
- Lead Sponsor
- General Hospital of Shenyang Military Region
- Brief Summary
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) has been found to improve neurological function and life ability of AIS patients and approved for the treatment of AIS by China Food and Drug Administration (CFDA). Our recent study imply that the neuroprotective effect of DELP involved multiple neuroprotective mechanism such as anti-inflammation, free radical scavenging, and decreasing MMP-9. Based on the multiple mechanisms, DELP was used to investigate the effect on acute ischemic stroke receiving endovascular treatment.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Age ≥18 years;
- acute anterior circulatory cerebral infarction with large vessel occlusion;
- NIHSS≥6 before endovascular treatment;
- good recanalization (TICI 2b-3);
- time from onset to groin puncture is less than 8 hours;
- time from recanalization to DELP is less than 2 hours;
- Premorbid mRS 0 or 1;
- Signed informed consent.
- poor recanalization (TICI 1-2a);
- Coagulation disorders, systematic hemorrhagic tendency, thrombocytopenia （ <100000/mm3;
- Severe hepatic or renal dysfunction, increase in ALT or AST (more than 2 times of upper limit of normal value), increase in serum creatinine (more than 1.5 times of upper limit of normal value) or requiring dialysis;
- Severe hypertension (systolic blood pressure over 200mmHg or diastolic blood pressure over 110 mmHg);
- Previous allergy to heparin or calcium;
- hypoproteinemia;
- Unsuitable for this clinical studies assessed by researcher.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Proportion of patients with modified Rankin Score 0 to 2 Day 90
- Secondary Outcome Measures
Name Time Method Proportion of patients with modified Rankin Score 0 to 1 Day 90 Changes in national institutes of health stroke scale (NIHSS) 7 days NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.
Changes in cerebral infarct volume 48 hours the occurence of stroke or other cardiovascular events Day 90 the occurence of infections post stroke Day 14 Proportion of symptomatic intracranial hemorrhage (sICH) 48 hours sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Proportion of intraparenchymal hemorrhage (PH1 and PH2) 48 hours the occurence of death due to any cause Day 90
Trial Locations
- Locations (1)
Department of Neurology, General Hospital of Northern Theater Command
🇨🇳Shenyang, China
Department of Neurology, General Hospital of Northern Theater Command🇨🇳Shenyang, China