Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    356
  • sponsor
    General Hospital of Shenyang Military Region
Updated on 22 March 2022

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). A 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, the investigator argues that DELP may exert neuroprotective effect on acute cerebral hemorrhage (ACH). In this context, the prospective, random, open-label, blind-endpoint, multi-centre study is designed.

Details
Condition Hemorrhagic Stroke
Treatment DELP
Clinical Study IdentifierNCT05128513
SponsorGeneral Hospital of Shenyang Military Region
Last Modified on22 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age: 18-80
Spontaneous cerebral hemorrhage
Deep supratentorial intracerebral hemorrhage (basal ganglia) with hematoma volume 5-40ml, or supratentorial lobar hemorrhages with hematoma volume 5-30ml
NIHSS: 6-20
Time from onset to DELP: 6-48 hours
Premorbid mRS 0 or 1
Signed informed consent

Exclusion Criteria

Secondary cerebral hemorrhage (secondary to trauma, tumor, vascular malformation, hemorrhage transformation of ischemic stroke, etc.)
Comatose patients on admission (GCS score 3-8 on the Glasgow Coma Scale)
Patients with intracerebral hemorrhage ruptured into the ventricle, which should be treated by surgery
Planed surgery
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), or hypotension (systolic blood pressure below 90mmHg or diastolic blood pressure below 60 mmHg)
Previous allergy to heparin or calcium
Life expectancy is less than 6 months due to comorbidity
Infected at the venipuncture site
hypoproteinemia
Unsuitable for this clinical studies assessed by researcher
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