- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03491956
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism
March 16, 2021 updated by: Jin HM, MD, Shanghai Pudong Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Huimin Jin, doctor
- Phone Number: 13917232915
- Email: hmjgli@163.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 201399
- Recruiting
- Shanghai Pudong Hospital
-
Contact:
- Huimin Jin, doctor
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- hyperlipidemia
Exclusion Criteria:
- Severe liver and kidney dysfunction
- Severe cardiopulmonary insufficiency
- tumor
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: DFPP group
self contrast (before and after DFPP)
|
Lipid levels,platelet function,and platelet RNA sequencing in hyperlipidemia patients before and after DFPP
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lipid levels
Time Frame: 1 year
|
reduce in lipid levels
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Platelet RNA sequencing
Time Frame: 1 year
|
whether the RNA sequencing of platelet changed ?
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bo Yu, doctor, Shanghai Pudong Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Anticipated)
April 1, 2021
Study Completion (Anticipated)
April 1, 2021
Study Registration Dates
First Submitted
April 2, 2018
First Submitted That Met QC Criteria
April 2, 2018
First Posted (Actual)
April 9, 2018
Study Record Updates
Last Update Posted (Actual)
March 17, 2021
Last Update Submitted That Met QC Criteria
March 16, 2021
Last Verified
March 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ShanghaiPudongH2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.