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Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03491956
Recruitment Status : Unknown
Verified February 2018 by Jin HM, MD, Shanghai Pudong Hospital.
Recruitment status was:  Recruiting
First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Information provided by (Responsible Party):
Jin HM, MD, Shanghai Pudong Hospital

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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 : February 1, 2019
Estimated Study Completion Date : February 1, 2019

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

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 ?

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Inclusion Criteria:

  1. hyperlipidemia

Exclusion Criteria:

  1. Severe liver and kidney dysfunction
  2. Severe cardiopulmonary insufficiency
  3. tumor
  4. pregnancy

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 identifier (NCT number): NCT03491956

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Contact: Huimin Jin, doctor 13917232915

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China, Shanghai
Shanghai Pudong Hospital Recruiting
Shanghai, Shanghai, China, 201399
Contact: Huimin Jin, doctor         
Sponsors and Collaborators
Shanghai Pudong Hospital
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Principal Investigator: Bo Yu, doctor Shanghai Pudong Hospital

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

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