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Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

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ClinicalTrials.gov Identifier: NCT03491956
Recruitment Status : Recruiting
First Posted : April 9, 2018
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Jin HM, MD, Shanghai Pudong Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
DFPP and Platelet Function Device: DFPP Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Double Filtration Plasmapheresis (DFPP) Improves Lipid Profile and Platelet Function in Hyperlipidemia Patients
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : April 1, 2021
Arms and Interventions
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Arm Intervention/treatment
DFPP group
self contrast (before and after DFPP)
 Device: DFPP
Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP


Outcome Measures
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Primary Outcome Measures :
  1. lipid levels [ Time Frame: 1 year ]
    reduce in lipid levels


Secondary Outcome Measures :
  1. Platelet RNA sequencing [ Time Frame: 1 year ]
    whether the RNA sequencing of platelet changed ?


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. hyperlipidemia

Exclusion Criteria:

  1. Severe liver and kidney dysfunction
  2. Severe cardiopulmonary insufficiency
  3. tumor
  4. pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03491956


Contacts
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Contact: Huimin Jin, doctor 13917232915 hmjgli@163.com

Locations
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China, Shanghai
Shanghai Pudong Hospital Recruiting
Shanghai, Shanghai, China, 201399
Contact: Huimin Jin, doctor         
Sponsors and Collaborators
Shanghai Pudong Hospital
Investigators
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Principal Investigator: Bo Yu, doctor Shanghai Pudong Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jin HM, MD, Professor, Shanghai Pudong Hospital
ClinicalTrials.gov Identifier: NCT03491956    
Other Study ID Numbers: ShanghaiPudongH2
First Posted: April 9, 2018    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No