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

Ischemic Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04708730
• Other study ID #: Y (2020) 043
• Status: Completed
• Phase: N/A
• Start date: August 15, 2021
• Est. completion date: February 8, 2024

Study information

• Verified date: March 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 8, 2024
• Est. primary completion date: November 3, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Device:
• Delipid Extracorporeal Lipoprotein filter from Plasma
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

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with modified Rankin Score 0 to 2		Day 90
Secondary	Proportion of patients with modified Rankin Score 0 to 1		Day 90
Secondary	Changes in national institutes of health stroke scale (NIHSS)	NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.	48 hours
Secondary	Changes in national institutes of health stroke scale (NIHSS)	NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.	7 days
Secondary	Changes in cerebral infarct volume		48 hours
Secondary	the occurence of stroke or other cardiovascular events		Day 90
Secondary	the occurence of infections post stroke		Day 14
Secondary	Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Secondary	Proportion of intraparenchymal hemorrhage (PH1 and PH2)		48 hours
Secondary	the occurence of death due to any cause		Day 90