Ischemic Stroke
Conditions
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.
Interventions
As a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke
Sponsors
General Hospital of Shenyang Military Region
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with modified Rankin Score 0 to 2 | Day 90 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Changes in cerebral infarct volume | 48 hours | — |
| the occurence of death due to any cause | Day 90 | — |
| Proportion of patients with modified Rankin Score 0 to 1 | Day 90 | — |
| Changes in national institutes of health stroke scale (NIHSS) | 48 hours | NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit. |
| Proportion of intraparenchymal hemorrhage (PH1 and PH2) | 48 hours | — |
Countries
China
Outcome results
None listed