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DELP for Acute Hemorrhagic Stroke

Sponsor
General Hospital of Shenyang Military Region (Other)
Overall Status
Terminated
CT.gov ID
NCT04708990
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
6.5
Actual Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Delipid Extracorporeal Lipoprotein filter from Plasma
 Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study
Actual Study Start Date :
Jan 12, 2021
Actual Primary Completion Date :
Jul 30, 2021
Actual Study Completion Date :
Jul 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: DELP

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
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
No Intervention: control group

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients with modified Rankin Score 0 to 2 [Day 90]

Secondary Outcome Measures

  1. Proportion of patients with modified Rankin Score 0 to 1 [Day 90]

  2. Changes in national institutes of health stroke scale (NIHSS) [48 hours]

    NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.

  3. changes of hematoma volume compared with the baseline [48 hours]

  4. changes of edema volume around hematoma compared with the baseline [48 hours]

  5. the occurence of death due to any cause [Day 90]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Neurology, General Hospital of Northern Theater Command Shenyang China 110016

Sponsors and Collaborators

  • General Hospital of Shenyang Military Region

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hui-Sheng Chen, Head of Neurology, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier:
NCT04708990
Other Study ID Numbers:
  • Y (2020) 044
First Posted:
Jan 14, 2021
Last Update Posted:
Nov 5, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hemorrhagic Stroke
Cerebral Hemorrhage
Hemorrhage

Study Results

No Results Posted as of Nov 5, 2021