DELP for Acute Hemorrhagic Stroke

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

Status and phase: Terminated; Phase 2

Conditions: Cerebral Hemorrhage

Treatments: Device: Delipid Extracorporeal Lipoprotein filter from Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT04708990

Y (2020) 044

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). 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, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.

Enrollment: 10 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 and thalamus) with hematoma volume 5-40ml;
• NIHSS: 4-22;
• Time from onset to DELP is less than 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;
• 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);
• Previous allergy to heparin or calcium;
• 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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10 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: Delipid Extracorporeal Lipoprotein filter from Plasma

control group

No Intervention group