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

NCT05128513 | Suspended DMC

• 1 other identifier: Y (2021) 38
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemorrhagic Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of patients with modified Rankin Score 0 to 1

  Day 90

• distribution of modified Rankin Score

  Day 90

• Changes in National Institute of Health stroke scale (NIHSS)

  24 hours and 2 weeks

• the occurence of stroke or other vascular events

  Day 90

• the changes in cerebral hematoma volume

  24 hours

Study Arms (2)

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

Device: DELP

control group

NO INTERVENTION

Interventions

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.

DELP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Shenyang Military Region: lead

Study Sites (1)

Department of Neurology, General Hospital of Northern Theater Command

Shenyang, 110016, China

Location

MeSH Terms

Conditions

Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Neurology

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 22, 2021
• Study Start: January 14, 2022
• Primary Completion (Estimated): April 8, 2027
• Study Completion (Estimated): April 8, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

CN (1)