NCT03491956

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

3.2 years

First QC Date

April 2, 2018

Last Update Submit

March 16, 2021

Conditions

DFPP and Platelet Function

Outcome Measures

Primary Outcomes (1)

  • lipid levels

    reduce in lipid levels

    1 year

Secondary Outcomes (1)

  • Platelet RNA sequencing

    1 year

Study Arms (1)

DFPP group

OTHER

self contrast (before and after DFPP)

Device: DFPP

Interventions

DFPPDEVICE

Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP

DFPP group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hyperlipidemia

You may not qualify if:

  • Severe liver and kidney dysfunction
  • Severe cardiopulmonary insufficiency
  • tumor
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201399, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 34307504DERIVED

Study Officials

  • Bo Yu, doctor

    Shanghai Pudong Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huimin Jin, doctor

CONTACT

13917232915hmjgli@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 9, 2018

Study Start

February 1, 2018

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

CN(1)