DELP for Acute Hemorrhagic Stroke

Cerebral Hemorrhage Clinical Trial

Official title:

DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04708990
• Other study ID #: Y (2020) 044
• Status: Terminated
• Phase: Phase 2
• Start date: January 12, 2021
• Est. completion date: July 30, 2021

Study information

• Verified date: October 2021
• 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). 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 30, 2021
• Est. primary completion date: July 30, 2021
• 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 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 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;

• 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.

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke

Intervention

Device:
• Delipid Extracorporeal Lipoprotein filter from Plasma
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

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		Day 90
Secondary	Proportion of patients with modified Rankin Score 0 to 1		Day 90
Secondary	Changes in national institutes of health stroke scale (NIHSS)	NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.	48 hours
Secondary	changes of hematoma volume compared with the baseline		48 hours
Secondary	changes of edema volume around hematoma compared with the baseline		48 hours
Secondary	the occurence of death due to any cause		Day 90