Back to resultsImproving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Delipid Extracorporeal Lipoprotein filter from Plasma
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
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.
Sites / Locations
- Department of Neurology, General Hospital of Northern Theater CommandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
DELP
control group
Arm Description
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration
Outcomes
Primary Outcome Measures
Proportion of patients with modified Rankin Score 0 to 2
Secondary Outcome Measures
Proportion of patients with modified Rankin Score 0 to 1
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.
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.
Changes in cerebral infarct volume
the occurence of stroke or other cardiovascular events
the occurence of infections post stroke
Proportion of symptomatic intracranial hemorrhage (sICH)
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
the occurence of death due to any cause
Full Information
NCT ID
NCT04708730
First Posted
January 11, 2021
Last Updated
August 20, 2023
Sponsor
General Hospital of Shenyang Military Region
1. Study Identification
Unique Protocol Identification Number
NCT04708730
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2021 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
DELP
Arm Type
Experimental
Arm Description
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Delipid Extracorporeal Lipoprotein filter from Plasma
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 2
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 1
Time Frame
Day 90
Title
Changes in national institutes of health stroke scale (NIHSS)
Description
NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.
Time Frame
48 hours
Title
Changes in national institutes of health stroke scale (NIHSS)
Description
NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.
Time Frame
7 days
Title
Changes in cerebral infarct volume
Time Frame
48 hours
Title
the occurence of stroke or other cardiovascular events
Time Frame
Day 90
Title
the occurence of infections post stroke
Time Frame
Day 14
Title
Proportion of symptomatic intracranial hemorrhage (sICH)
Description
sICH was defined as 4 or more increase in NIHSS caused by hemorrhage
Time Frame
48 hours
Title
Proportion of intraparenchymal hemorrhage (PH1 and PH2)
Time Frame
48 hours
Title
the occurence of death due to any cause
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, Ph.D.
Phone
+86 13352452086
Email
chszh@aliyun.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be shared in request after the trial finish and will include study protocol, statistical analysis plan.
Learn more about this trial
Improving Neuroprotective Strategy for Ischemic Stroke After Thrombectomy Followed by DELP (INSIST-DELP)
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