Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism | NCT03491956

Studies
Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

NCT03491956

Sponsor

Shanghai Pudong Hospital

Status

Unknown status

Last Update Posted

Mar 17, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

DFPP and Platelet Function

Interventions

DFPP

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2018Actual

Primary Completion Date

Apr 1, 2021Estimated

Completion Date

Apr 1, 2021Estimated

First Submitted Date

Apr 2, 2018

First Submission Date that Met QC Criteria

Apr 2, 2018

First Posted Date

Apr 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2021

Last Update Posted Date

Mar 17, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
DFPP group	Other	self contrast (before and after DFPP)	Device: DFPP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DFPP	Device	Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP	DFPP group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
lipid levels	reduce in lipid levels	1 year

Secondary Outcomes

Measure	Description	Time Frame
Platelet RNA sequencing	whether the RNA sequencing of platelet changed ?	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hyperlipidemia

Exclusion Criteria:

Severe liver and kidney dysfunction
Severe cardiopulmonary insufficiency
tumor
pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Huimin Jin, doctor	Contact	13917232915		hmjgli@163.com

Overall Officials

Name	Affiliation	Role
Bo Yu, doctor	Shanghai Pudong Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Pudong Hospital	Recruiting	Shanghai	Shanghai Municipality	201399	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34307504	Derived	Zhang 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.