Trials Sponsors Conditions Drugs Pricing

Conditions

Age-Related Frailty

Outcome Measures

Primary Outcomes (1)

Change in Canadian Study of Health and Aging (CSHA) Clinical Frailty Scale
A global clinical measure of fitness and frailty in elderly people, ranging from 1-9, with 1 being 'Very Fit', and 9 being 'Terminally I'll'. Reduction in score from higher to lower is to be seen as improvement in frailty.
Change in Scale Score after completion of study (6 months)

Study Arms (1)

Experimental Group (Plasmapheresis for Age-Related Frailty)

EXPERIMENTAL

Participants will receive plasmapheresis once a month for six months. All participants will be in this arm.

Other: Therapeutic Plasma Exchange (TPE)

Interventions

Therapeutic Plasma Exchange (TPE)Other

Following all necessary screening and consenting protocol, patients will be scheduled for the plasmapheresis procedure. Plasmapheresis On the days of the scheduled procedure, patients will undergo up to 1.5 hours of plasmapheresis treatment. Patients will be awake and situated in a relaxed position in a reclined chair. The plasmapheresis device to be used is the Fresenius Kabi 'Amicus', which is currently FDA approved for a variety of clinical conditions. In one treatment, roughly 60-70% of a patient's plasma can safely be replaced; by using six consecutive treatments, more of the patient's plasma (approaching 100%) will be replaced in an exponential fashion.

Also known as: Plasmapheresis

Experimental Group (Plasmapheresis for Age-Related Frailty)

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age50 Years - 95 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age eligibility requirements fall in a range from 50 to 95 years of age
Clinical appraisal by physician indicating signs of frailty (apart from a co-occurring condition), scoring 3\<x \<7 as denoted by the CSHA Clinical Frailty Scale (see Appendix A; Rockwood, Song, MacKnight, et al, 2005; Golpanian, DiFede, Pujol, et al., 2016)

Sponsors & Collaborators

Neurological Associates of West Los Angeles
Otherlead

Study Sites (1)

Neurological Associates - The Interventional Group

Santa Monica, California, 90403, United States

MeSH Terms

Interventions

Plasma ExchangePlasmapheresis

Intervention Hierarchy (Ancestors)

Blood TransfusionBiological TherapyTherapeuticsBlood Component RemovalSorption DetoxificationExtracorporeal CirculationSurgical Procedures, Operative

Study Officials

Sheldon Jordan, M.D.
Neurological Associates The Interventional Group
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: early phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 30, 2021

First Posted

September 23, 2021

Study Start

March 19, 2021

Actual (reported)

Primary Completion

April 2025

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Plasmapheresis for Treatment of Age-Related Frailty

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental Group (Plasmapheresis for Age-Related Frailty)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Experimental Group (Plasmapheresis for Age-Related Frailty)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations