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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DELP | Experimental | Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration |
|
| control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DELP | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, General Hospital of Northern Theater Command | Shenyang | 110016 | China |
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| ID | Term |
|---|---|
| D000083302 | Hemorrhagic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |