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Completed

NCT Number: NCT04708730

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Delipid Extracorporeal Lipoprotein filter from Plasma

Device

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 outcomes

  1. Proportion of patients with modified Rankin Score 0 to 2

    Time frame: Day 90

Secondary outcomes

  1. Proportion of patients with modified Rankin Score 0 to 1

    Time frame: Day 90

  2. Changes in national institutes of health stroke scale (NIHSS)

    Time frame: 48 hours

    NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.

  3. Changes in national institutes of health stroke scale (NIHSS)

    Time frame: 7 days

    NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.

  4. Changes in cerebral infarct volume

    Time frame: 48 hours

  5. the occurence of stroke or other cardiovascular events

    Time frame: Day 90

  6. the occurence of infections post stroke

    Time frame: Day 14

  7. Proportion of symptomatic intracranial hemorrhage (sICH)

    Time frame: 48 hours

    sICH was defined as 4 or more increase in NIHSS caused by hemorrhage

  8. Proportion of intraparenchymal hemorrhage (PH1 and PH2)

    Time frame: 48 hours

  9. the occurence of death due to any cause

    Time frame: Day 90

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jan 14, 2021
Registry last updated
Mar 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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