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NCT05128513 | Suspended | Hemorrhagic Stroke

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

General Hospital of Shenyang Military Region

Information provided by (Responsible Party):

Hui-she NGC is very

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). 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.

Condition or disease

Hemorrhagic Stroke

Intervention/treatment

DELP

Phase

Not Applicable

Study Type : Interventional
Estimated Enrollment : 356 participants
Masking : Single
Primary Purpose : Treatment
Official Title : Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
Actual Study Start Date : January 14, 2022
Estimated Primary Completion Date : February 8, 2026
Estimated Study Completion Date : February 8, 2026
Arm Intervention/treatment

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

No Intervention: control group

Ages Eligible for Study: 18 Years to 80 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
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.
Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke

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

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Locations

Not yet recruiting

China,

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China, 110016