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Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)

Not Applicable
Completed
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
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Proportion of patients with modified Rankin Score 0 to 2Day 90
Secondary Outcome Measures
NameTimeMethod
Proportion of patients with modified Rankin Score 0 to 1Day 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 volume48 hours
the occurence of stroke or other cardiovascular eventsDay 90
the occurence of infections post strokeDay 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 causeDay 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

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