Clinical trial NCT05128513: Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke
Official title: Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Hemorrhagic Stroke
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2021-11-22
Enrollment: 356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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). 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 2
timeFrame: Day 90
Secondary outcomes:
measure: Proportion of patients with modified Rankin Score 0 to 1
timeFrame: Day 90
measure: distribution of modified Rankin Score
timeFrame: Day 90
measure: Changes in National Institute of Health stroke scale (NIHSS)
timeFrame: 24 hours and 2 weeks
measure: the occurence of stroke or other vascular events
timeFrame: Day 90
measure: the changes in cerebral hematoma volume
timeFrame: 24 hours
measure: the severe adverse events
timeFrame: 24 hours
measure: the occurence of death due to any cause
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Shenyang
country: China
facility: Department of Neurology, General Hospital of Northern Theater Command
Study officials:
References: