Cerebral HemorrhagePhase 2NCT04708990
DELP for Acute Hemorrhagic Stroke
A Phase 2 study testing Delipid Extracorporeal Lipoprotein filter from Plasma in people with Cerebral Hemorrhage, 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
- Cerebral Hemorrhage
- What is being tested?
- Delipid Extracorporeal Lipoprotein filter from Plasma
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 12 Jan 2021to 30 Jul 2021
- Phase
- Phase 2
- 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 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;
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;
- 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);
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- Previous allergy to heparin or calcium;
- 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: DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot 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). 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.
- Conditions
- Cerebral Hemorrhage
- Being tested
- Delipid Extracorporeal Lipoprotein filter from Plasma
- Medical subject headings
- Cerebral Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delipid Extracorporeal Lipoprotein filter from PlasmaDevice
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
| 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: Delipid Extracorporeal Lipoprotein filter from Plasma |
| 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
Measured: Day 90
Secondary outcomes (5)
Proportion of patients with modified Rankin Score 0 to 1
Measured: Day 90
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.
Measured: 48 hours
changes of hematoma volume compared with the baseline
Measured: 48 hours
changes of edema volume around hematoma compared with the baseline
Measured: 48 hours
the occurence of death due to any cause
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start12 Jan 2021
- Primary completion30 Jul 2021
- Study completion30 Jul 2021
Why it stopped: the research sponsors stopped further funding due to a planning of a multi-center trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral HemorrhageStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (actual)
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
- NCT04708990
- Sponsor's protocol ID
- Y (2020) 044
- Status last verified
- Oct 2021
- First submitted
- 11 Jan 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELP for Acute Hemorrhagic Stroke: a Prospective, Random, Open-label, Blind-endpoint, Single Centre, Pilot Study
- ClinicalTrials.gov ID
- NCT04708990
- Acronym / sponsor ID
- Y (2020) 044
- Conditions
- Cerebral Hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: the research sponsors stopped further funding due to a planning of a multi-center trial
- Enrolment
- 10 participants (actual)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 Jan 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). 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.
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: Delipid Extracorporeal Lipoprotein filter from PlasmaDelipid 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 and thalamus) with hematoma volume 5-40ml;
- NIHSS: 4-22;
- Time from onset to DELP is less than 48 hours;
Key exclusion criteria (9 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;
- 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 |
|---|---|---|
| Delipid Extracorporeal Lipoprotein filter from PlasmaAs a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke | Device | DELP |
Primary outcome
Proportion of patients with modified Rankin Score 0 to 2
Time frame: Day 90
5 secondary outcomes
Proportion of patients with modified Rankin Score 0 to 1
Time frame: Day 90
Changes in national institutes of health stroke scale (NIHSS)
Time frame: 48 hours
changes of hematoma volume compared with the baseline
Time frame: 48 hours
changes of edema volume around hematoma compared with the baseline
Time frame: 48 hours
the occurence of death due to any cause
Time frame: Day 90
Results and safety
The study was stopped early (reason given: the research sponsors stopped further funding due to a planning of a multi-center trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
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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 Phase 2 study testing Delipid Extracorporeal Lipoprotein filter from Plasma in people with Cerebral Hemorrhage, 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 9 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: stopped early, as of the sponsor's last update on 5 Nov 2021. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: the research sponsors stopped further funding due to a planning of a multi-center trial). 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 5 Nov 2021.