DELP for Acute Hemorrhagic Stroke

Study Overview
=================
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). 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.

Official Title
-----------------
DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study

Conditions
-----------------
Cerebral Hemorrhage

Intervention / Treatment
-----------------
* Device: Delipid Extracorporeal Lipoprotein filter from Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Delipid Extracorporeal Lipoprotein filter from Plasma<br>* 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<br>|
| No Intervention: control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 2 |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with modified Rankin Score 0 to 1 |  | 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. | 48 hours | 
| changes of hematoma volume compared with the baseline |  | 48 hours | 
| changes of edema volume around hematoma compared with the baseline |  | 48 hours | 
| the occurence of death due to any cause |  | Day 90 |