DELP for Acute Hemorrhagic Stroke

NCT04708990 | Terminated Phase 2 DMC

• 1 other identifier: Y (2020) 044
• Study Type: interventional
• Target: 10
• 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). Our 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, we argue that DELP may exert neuroprotective effect on acute cerebral hemorrhage.

Conditions

Cerebral Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with modified Rankin Score 0 to 2

  Day 90

Secondary Outcomes (5)

• Proportion of patients with modified Rankin Score 0 to 1

  Day 90

• Changes in national institutes of health stroke scale (NIHSS)

  48 hours

• changes of hematoma volume compared with the baseline

  48 hours

• changes of edema volume around hematoma compared with the baseline

  48 hours

• the occurence of death due to any cause

  Day 90

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: Delipid Extracorporeal Lipoprotein filter from Plasma

control group

NO INTERVENTION

Interventions

Delipid Extracorporeal Lipoprotein filter from Plasma DEVICE

As a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke

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 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;

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;
• 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.

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

Cerebral Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 11, 2021
• First Posted: January 14, 2021
• Study Start: January 12, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-10

Locations

CN (1)