Clinical trial NCT04708730: Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
Official title: Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-01-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: Day 90
measure: Changes in national institutes of health stroke scale (NIHSS)
timeFrame: 48 hours
measure: Changes in national institutes of health stroke scale (NIHSS)
timeFrame: 7 days
measure: Changes in cerebral infarct volume
timeFrame: 48 hours
measure: the occurence of stroke or other cardiovascular events
timeFrame: Day 90
measure: the occurence of infections post stroke
timeFrame: Day 14
measure: Proportion of symptomatic intracranial hemorrhage (sICH)
timeFrame: 48 hours
measure: Proportion of intraparenchymal hemorrhage (PH1 and PH2)
timeFrame: 48 hours
measure: the occurence of death due to any cause
timeFrame: Day 90
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: