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DELP for Acute Hemorrhagic Stroke

Primary Purpose

Cerebral Hemorrhage

Status
Terminated
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Delipid Extracorporeal Lipoprotein filter from Plasma
Sponsored by
General Hospital of Shenyang Military Region
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Hemorrhage

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater Command

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

DELP

control group

Arm Description

Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration

Outcomes

Primary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 2

Secondary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 1
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.
changes of hematoma volume compared with the baseline
changes of edema volume around hematoma compared with the baseline
the occurence of death due to any cause

Full Information

First Posted
January 11, 2021
Last Updated
October 28, 2021
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT04708990
Brief Title
DELP for Acute Hemorrhagic Stroke
Official Title
DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Terminated
Why Stopped
the research sponsors stopped further funding due to a planning of a multi-center trial
Study Start Date
January 12, 2021 (Actual)
Primary Completion Date
July 30, 2021 (Actual)
Study Completion Date
July 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital of Shenyang Military Region

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DELP
Arm Type
Experimental
Arm Description
Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Delipid Extracorporeal Lipoprotein filter from Plasma
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 2
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 1
Time Frame
Day 90
Title
Changes in national institutes of health stroke scale (NIHSS)
Description
NIHSS ranges from 0-42, and the decrease in NIHSS means the improvement of neurological deficit.
Time Frame
48 hours
Title
changes of hematoma volume compared with the baseline
Time Frame
48 hours
Title
changes of edema volume around hematoma compared with the baseline
Time Frame
48 hours
Title
the occurence of death due to any cause
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China

12. IPD Sharing Statement

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DELP for Acute Hemorrhagic Stroke

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