Hemorrhagic StrokeNCT05128513
Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke
A study testing DELP in people with Hemorrhagic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemorrhagic Stroke
- What is being tested?
- DELP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to 8 Apr 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurology, General Hospital of Northern Theater Command
Shenyang, 110016
About this study
Official title: Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
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.
- Conditions
- Hemorrhagic Stroke
- Being tested
- DELP
- Medical subject headings
- Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DELPDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: DELP |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 90
Secondary outcomes (7)
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
Measured: Day 90
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
Measured: Day 90
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
Measured: 24 hours and 2 weeks
the occurence of stroke or other vascular events
Measured: Day 90
the changes in cerebral hematoma volume
the hematoma volume was formulated by brain CT
Measured: 24 hours
the severe adverse events
Measured: 24 hours
the occurence of death due to any cause
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start14 Jan 2022
- Primary completion8 Apr 2027 (estimated)
- Study completion8 Apr 2027 (estimated)
Why it stopped: Funding issues from sponsors
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 356 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hui-Sheng Chen, General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128513
- Sponsor's protocol ID
- Y (2021) 38
- Status last verified
- Apr 2026
- First submitted
- 29 Oct 2021
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delipid Extracorporeal Lipoprotein Filter From Plasma (DELP) for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Multi-centre Study
- ClinicalTrials.gov ID
- NCT05128513
- Acronym / sponsor ID
- Y (2021) 38
- Conditions
- Hemorrhagic Stroke
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Funding issues from sponsors
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 8 Apr 2027 (estimated)
- Study completion
- 8 Apr 2027 (estimated)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DELP | Experimental | Device: DELPDelipid Extracorporeal Lipoprotein filter from Plasma (DELP) is a non-pharmacological therapy for acute stroke, which is approved by China Food and Drug Administration |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DELPThe 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. | Device | DELP |
Primary outcome
Proportion of patients with modified Rankin Score 0 to 2
Time frame: Day 90
the minimum and maximum values of modified Rankin Score are 0 and 6, respectively; higher score mean a worse outcome
7 secondary outcomes
Proportion of patients with modified Rankin Score 0 to 1
Time frame: Day 90
distribution of modified Rankin Score
Time frame: Day 90
Changes in National Institute of Health stroke scale (NIHSS)
Time frame: 24 hours and 2 weeks
the occurence of stroke or other vascular events
Time frame: Day 90
the changes in cerebral hematoma volume
Time frame: 24 hours
the severe adverse events
Time frame: 24 hours
the occurence of death due to any cause
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DELP in people with Hemorrhagic Stroke, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with modified Rankin Score 0 to 2 (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.