DELP for Acute Hemorrhagic Stroke

Phase 2TerminatedNCT04708990

General Hospital of Shenyang Military Region10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cerebral Hemorrhage

Interventions

Delipid Extracorporeal Lipoprotein filter from PlasmaDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, China

Outcomes

Primary Outcomes

Proportion of patients with modified Rankin Score 0 to 2

Time frame: Day 90

Secondary Outcomes

Proportion of patients with modified Rankin Score 0 to 1

Time frame: Day 90

Changes in national institutes of health stroke scale (NIHSS)

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

Time frame: 48 hours

changes of hematoma volume compared with the baseline

Time frame: 48 hours

changes of edema volume around hematoma compared with the baseline

Time frame: 48 hours

the occurence of death due to any cause

Time frame: Day 90

Data from ClinicalTrials.gov

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