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

Not Applicable

Suspended

• Conditions: Hemorrhagic Stroke

• Registration Number: NCT05128513
• Lead Sponsor: General Hospital of Shenyang Military Region

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-29
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-22
• Study Start: 2022-01-14
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-02-08
• Study Completion: 2026-02-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 356

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of patients with modified Rankin Score 0 to 2	Day 90	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

Secondary Outcome Measures

Name	Time	Method
Changes in National Institute of Health stroke scale (NIHSS)	24 hours and 2 weeks	the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
the severe adverse events	24 hours
distribution of modified Rankin Score	Day 90	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Proportion of patients with modified Rankin Score 0 to 1	Day 90	the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
the occurence of stroke or other vascular events	Day 90
the changes in cerebral hematoma volume	24 hours	the hematoma volume was formulated by brain CT
the occurence of death due to any cause	2 weeks

Trial Locations

Locations (1)

Department of Neurology, General Hospital of Northern Theater Command; 🇨🇳 Shenyang, China