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

Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP): a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study

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.

Study Overview

• Status: Completed
• Conditions: Ischemic Stroke
• Intervention / Treatment: Device: Delipid Extracorporeal Lipoprotein filter from Plasma

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shenyang, China, 110016
    • Department of Neurology, General Hospital of Northern Theater Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: DELP; Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with modified Rankin Score 0 to 2	Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of symptomatic intracranial hemorrhage (sICH)	sICH was defined as 4 or more increase in NIHSS caused by hemorrhage	48 hours
Proportion of patients with modified Rankin Score 0 to 1		Day 90
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
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
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 intraparenchymal hemorrhage (PH1 and PH2)		48 hours
the occurence of death due to any cause		Day 90

Collaborators and Investigators

• Sponsor: General Hospital of Shenyang Military Region

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2021
• Primary Completion (Actual): November 3, 2023
• Study Completion (Actual): February 8, 2024

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 14, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Stroke; Ischemic Stroke; Ischemia; Cerebral Infarction
• Other Study ID Numbers: Y (2020) 043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD will be shared in request after the trial finish and will include study protocol, statistical analysis plan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No