DFPP and Platelet FunctionNCT03491956
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism
A study testing DFPP in people with DFPP and Platelet Function, run by Shanghai Pudong Hospital at 1 site in China.
Trial summary
Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- DFPP and Platelet Function
- What is being tested?
- DFPP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to 1 Apr 2021
- 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
- hyperlipidemia
Who cannot join
- Severe liver and kidney dysfunction
- Severe cardiopulmonary insufficiency
- tumor
- pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Huimin Jin, doctor
About this study
Official title: Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients
Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.
- Conditions
- DFPP and Platelet Function
- Being tested
- DFPP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DFPPDevice
Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP
| Study group | Role | What they receive |
|---|---|---|
| DFPP group | Other | self contrast (before and after DFPP) Receives: Device: DFPP |
What is being measured
The primary outcome is the main question the study is designed to answer.
lipid levels
reduce in lipid levels
Measured: 1 year
Secondary outcomes (1)
Platelet RNA sequencing
whether the RNA sequencing of platelet changed ?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start1 Feb 2018
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DFPP and Platelet FunctionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin HM, MD, Shanghai Pudong Hospital
- Investigators
- Bo Yu, doctor, Principal investigator, Shanghai Pudong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491956
- Sponsor's protocol ID
- ShanghaiPudongH2
- Status last verified
- Mar 2021
- First submitted
- 2 Apr 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cheng Y, Li L, Yang Q, Wu M. Effect of DFPP on Ferroptosis in Peripheral Blood CD14+ Monocytes of Hyperlipidemic Patients Involving the ACSL4/LPCAT3/ALOX5 Pathway. Ther Apher Dial. 2026 Oct 7. doi: 10.1002/1744-9987.70227. Online ahead of print.
PubMed 42843813Zhang XM, Gu YH, Deng H, Xu ZQ, Zhong ZY, Lyu XJ, Jin HM, Yang XH. Plasma Purification Treatment Relieves the Damage of Hyperlipidemia to PBMCs. Front Cardiovasc Med. 2021 Jul 7;8:691336. doi: 10.3389/fcvm.2021.691336. eCollection 2021.
PubMed 34307504
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients
- ClinicalTrials.gov ID
- NCT03491956
- Acronym / sponsor ID
- ShanghaiPudongH2
- Conditions
- DFPP and Platelet Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 9 Apr 2018 (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.
Little clinic trials showed that Double Filtration Plasmapheresis (DFPP) could improve lipid metabolism, however, whether DFPP can improve platelet function and recover Endothelial function is unknown. In this study, we try to confirm the hypothesis that DFPP can improve endothelial function in hyperlipidemia patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DFPP group | Other | Device: DFPPself contrast (before and after DFPP) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- hyperlipidemia
Key exclusion criteria (4 listed)
- Severe liver and kidney dysfunction
- Severe cardiopulmonary insufficiency
- tumor
- pregnancy
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 |
|---|---|---|
| DFPPLipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP | Device | DFPP group |
Primary outcome
lipid levels
Time frame: 1 year
reduce in lipid levels
1 secondary outcome
Platelet RNA sequencing
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Derived from this study: PubMed 42843813Cheng Y, Li L, Yang Q, Wu M. Effect of DFPP on Ferroptosis in Peripheral Blood CD14+ Monocytes of Hyperlipidemic Patients Involving the ACSL4/LPCAT3/ALOX5 Pathway. Ther Apher Dial. 2026 Oct 7. doi: 10.1002/1744-9987.70227. Online ahead of print.
- Derived from this study: PubMed 34307504Zhang XM, Gu YH, Deng H, Xu ZQ, Zhong ZY, Lyu XJ, Jin HM, Yang XH. Plasma Purification Treatment Relieves the Damage of Hyperlipidemia to PBMCs. Front Cardiovasc Med. 2021 Jul 7;8:691336. doi: 10.3389/fcvm.2021.691336. eCollection 2021.
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.
Bo Yu, doctor principal investigator
Shanghai Pudong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DFPP in people with DFPP and Platelet Function, run by Shanghai Pudong Hospital 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Mar 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.
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?
Contact Huimin Jin, doctor (13917232915, hmjgli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
lipid levels (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03491956, which also lists 2 linked publications.
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 17 Mar 2021.