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

Study Overview
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Brief Summary
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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.

Official Title
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Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study

Conditions
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Hemorrhagic Stroke

Intervention / Treatment
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* Device: DELP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DELP<br>Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration | Device: DELP<br>* The blood was pumped into the PCS2 plasma separator through one side of the forearm vein. The plasma was separated by pump and then sent to the DELP system (Shanghai Jiangxia Blood Technology Co.). After purification, the plasma was returned to the patient via another forearm vein. The total treatment plasma volume was 800-1,000 mL; the anticoagulant 4% sodium citrate dehydrate solution with a ratio of 1:16 to plasma, was dropped before pumping. To prevent hypocalcemia, 500 mg CaCl2 diluted with 250 mL physiological saline was infused at a rate of 150 mL/h, in the first cycle of the returning blood transfusion.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 2 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 
| distribution of modified Rankin Score | the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome | Day 90 | 
| Changes in National Institute of Health stroke scale (NIHSS) | the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome | 24 hours and 2 weeks | 
| the occurence of stroke or other vascular events |  | Day 90 | 
| the changes in cerebral hematoma volume | the hematoma volume was formulated by brain CT | 24 hours | 
| the severe adverse events |  | 24 hours | 
| the occurence of death due to any cause |  | 2 weeks |