Double Filtration Plasmapheresis (DFPP) and Lipid Metabolism

• Sponsor: Shanghai Pudong Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03491956
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 37.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Anticipated 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: Feb 1, 2018
• Anticipated Primary Completion Date: Apr 1, 2021
• Anticipated Study Completion Date: Apr 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Primary Outcome Measures

1. lipid levels [1 year]

   reduce in lipid levels

Secondary Outcome Measures

1. Platelet RNA sequencing [1 year]

   whether the RNA sequencing of platelet changed ?

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Pudong Hospital	Shanghai	Shanghai	China	201399

Sponsors and Collaborators

• Shanghai Pudong Hospital

Investigators

• Principal Investigator: Bo Yu, doctor, Shanghai Pudong Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jin HM, MD, Professor, Shanghai Pudong Hospital
• ClinicalTrials.gov Identifier: NCT03491956
• Other Study ID Numbers: ShanghaiPudongH2
• First Posted: Apr 9, 2018
• Last Update Posted: Mar 17, 2021
• Last Verified: Mar 1, 2021

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

Study Results

No Results Posted as of Mar 17, 2021