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

Primary Purpose

Hemorrhagic Stroke

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
DELP
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 Hemorrhagic Stroke

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) 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;

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, 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.

Sites / Locations

  • Department of Neurology, General Hospital of Northern Theater CommandRecruiting

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
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome

Secondary Outcome Measures

Proportion of patients with modified Rankin Score 0 to 1
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
distribution of modified Rankin Score
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Changes in National Institute of Health stroke scale (NIHSS)
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
the occurence of stroke or other vascular events
the changes in cerebral hematoma volume
the hematoma volume was formulated by brain CT
the severe adverse events
the occurence of death due to any cause

Full Information

First Posted
October 29, 2021
Last Updated
February 15, 2023
Sponsor
General Hospital of Shenyang Military Region
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1. Study Identification

Unique Protocol Identification Number
NCT05128513
Brief Title
Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke
Official Title
Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
356 (Anticipated)

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)
DELP
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 2
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Secondary Outcome Measure Information:
Title
Proportion of patients with modified Rankin Score 0 to 1
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Title
distribution of modified Rankin Score
Description
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
Time Frame
Day 90
Title
Changes in National Institute of Health stroke scale (NIHSS)
Description
the minimum and maximum values of NIHSS are 0 and 42, respectively; higher NIHSS mean a worse outcome
Time Frame
24 hours and 2 weeks
Title
the occurence of stroke or other vascular events
Time Frame
Day 90
Title
the changes in cerebral hematoma volume
Description
the hematoma volume was formulated by brain CT
Time Frame
24 hours
Title
the severe adverse events
Time Frame
24 hours
Title
the occurence of death due to any cause
Time Frame
2 weeks

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) 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; 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, 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui-Sheng Chen
Phone
+8624897511
Email
chszh@aliyun.com
Facility Information:
Facility Name
Department of Neurology, General Hospital of Northern Theater Command
City
Shenyang
ZIP/Postal Code
110016
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui-Sheng Chen, Ph.D.
Phone
+86 13352452086
Email
chszh@aliyun.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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