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

General Hospital of Northern Theater Command of Chinese People's Liberation Army

Status: Suspended

Conditions: Hemorrhagic Stroke

Treatments: Device: DELP

Study type: Interventional

Funder types: Other

Identifiers

NCT05128513

Y (2021) 38

Details and patient eligibility

About

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.

Enrollment: 356 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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356 participants in 2 patient groups

DELP

Experimental group

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

Treatment:

Device: DELP

control group

No Intervention group