Status:
TERMINATED
DELP for Acute Hemorrhagic Stroke
Lead Sponsor:
General Hospital of Shenyang Military Region
Conditions:
Cerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 Dr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04708990
Start Date
January 12 2021
End Date
July 30 2021
Last Update
November 5 2021
Active Locations (1)
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1
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, China, 110016