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

Hemorrhagic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05128513
• Other study ID #: Y (2021) 38
• Status: Suspended
• Phase: N/A
• Start date: January 14, 2022
• Est. completion date: February 8, 2026

Study information

• Verified date: March 2024
• Source: General Hospital of Shenyang Military Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 356
• Est. completion date: February 8, 2026
• Est. primary completion date: February 8, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhagic Stroke
• Stroke

Intervention

Device:
• DELP
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.

Locations

Country	Name	City	State
China	Department of Neurology, General Hospital of Northern Theater Command	Shenyang

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital of Shenyang Military Region

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	the occurence of stroke or other vascular events		Day 90
Secondary	the changes in cerebral hematoma volume	the hematoma volume was formulated by brain CT	24 hours
Secondary	the severe adverse events		24 hours
Secondary	the occurence of death due to any cause		2 weeks