Human Albumin Combined With Plasma Exchange for Frailty Intervention

NCT07836127 | Not Yet Recruiting

• 1 other identifier: IIT2026049
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Background Frailty is an age-related syndrome characterized by reduced physiological reserve, decreased stress tolerance and multisystem functional decline in the elderly, which markedly increases the risks of falls, hospitalization, functional impairment and all-cause mortality. Chronic low-grade inflammation, immune senescence, oxidative stress and abnormal protein modification are key mechanisms underlying the development and progression of frailty. Current mainstream interventions including nutritional support and physical exercise yield limited efficacy for moderate to severe frailty, and targeted therapies against biological aging mechanisms are still lacking.Objective To evaluate the efficacy and safety of plasma exchange combined with human albumin (ALB), with or without intravenous immunoglobulin (IVIg), in the treatment of frailty, and to preliminarily explore the potential mechanisms of the combined therapy.Methods This is a prospective, randomized, exploratory clinical trial. A total of 34 participants with a FRAIL scale score ≥ 1 will be enrolled and randomly assigned at a 1:1 ratio into two groups, with 17 cases in each group: the plasma exchange plus ALB group and the plasma exchange plus ALB plus IVIg group. The study consists of a screening phase, a 5-month treatment phase with six intervention sessions, and follow-up visits at 1, 3 and 6 months after the final treatment. Frailty status, physical function, laboratory parameters, inflammatory levels and albumin modification will be dynamically assessed throughout the trial, and adverse events will be recorded.Results The trial has not yet been initiated. It is expected that the within-group and between-group comparisons will clarify the therapeutic effects and long-term stability of the two regimens, as well as their safety profiles. Changes in biomarkers will help illustrate the potential molecular mechanisms of plasma purification combined with functional protein supplementation for frailty.Conclusion Plasma exchange combined with ALB (with or without IVIg) can exert multi-target intervention on frailty by eliminating aging-related toxic factors and restoring plasma and immune homeostasis. The findings of this study will provide preliminary clinical evidence and theoretical basis for novel biological therapeutic strategies for frailty.

Conditions

Frailty; Plasma Exchange

Outcome Measures

Primary Outcomes (1)

• Efficacy rate of frailty intervention at 1 month after the last treatment

  Calculation formula: \[(Baseline score - Follow-up score at 1 month after the last treatment) / Baseline score\] × 100%. This rate represents the degree of improvement in patients' frailty status following intervention.

  1 month after the last treatment

Secondary Outcomes (23)

• Efficacy rate of frailty intervention assessed by FRAIL Scale

  Baseline, 4 week, 8 week, 12 week, 16 week, 20 week, 24 week, 28 week, and 32 week after enrollment

• Strand specificity of frailty-related cfDNA and therapeutic response to plasma exchange

  Baseline, 1 month and 6 months after the last treatment

• Clonal hematopoiesis gene mutation dynamics and correlation with frailty

  Baseline, 4 week,24 week, 28 week, and 32 week after enrollment

• BCR clonotype characteristics

  Baseline, 1 month and 6 months after the last treatment

• BCR V/J gene usage bias

  Baseline, 1 month and 6 months after the last treatment

Study Arms (2)

Plasma Exchange + Human Albumin Group

EXPERIMENTAL

All subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin as replacement fluid, no IVIg administration.

Procedure: Plasma Exchange; Biological: 5% human albumin

Experimental: Plasma Exchange + Human Albumin + IVIg Group

EXPERIMENTAL

All subjects receive standard background therapy. Subjects receive monthly plasma exchange for 6 cycles with 5% human albumin replacement fluid, plus IVIg 2.5 g after each exchange session.

Procedure: Plasma Exchange; Biological: 5% human albumin; Biological: Intravenous immunoglobulin (IVIG)

Interventions

Plasma Exchange PROCEDURE

Plasma exchange procedure, target exchange volume 50±5 mL/kg per session, flow rate 40-60 mL/min, administered once monthly for 6 cycles.

Experimental: Plasma Exchange + Human Albumin + IVIg Group; Plasma Exchange + Human Albumin Group

5% human albumin BIOLOGICAL

Equal-volume 5% human albumin solution used as replacement fluid during plasma exchange.

Experimental: Plasma Exchange + Human Albumin + IVIg Group; Plasma Exchange + Human Albumin Group

Intravenous immunoglobulin (IVIG) BIOLOGICAL

IVIg administered at a fixed dose of 2.5 g per subject, infused immediately after each plasma exchange session.

Experimental: Plasma Exchange + Human Albumin + IVIg Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Clear consciousness and ability to communicate.
• Sufficient cognitive function and educational level to complete all study-related assessments.
• A score of ≥ 1 on the FRAIL scale.
• Voluntary written informed consent.

You may not qualify if:

• Known allergy or hypersensitivity to albumin (ALB) or intravenous immunoglobulin (IVIg).
• Currently receiving albumin (ALB) and/or intravenous immunoglobulin (IVIg) infusion for other reasons.
• Severe cardiac, hepatic, or renal insufficiency.
• Active infection or acute exacerbation of chronic infection.
• Current use of direct oral anticoagulants (DOACs).
• History of bleeding disorders or coagulation dysfunction.
• Concomitant malignancy or expected survival of less than 6 months.
• Severe visual, auditory, or motor function impairment.
• Refusal to sign the informed consent form.
• Other conditions that, in the opinion of the investigator, make the participant unsuitable for the study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, 300041, China

Location

MeSH Terms

Conditions

Frailty

Interventions

Plasma Exchange; Serum Albumin, Human; Immunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Serum Globulins; Globulins

Central Study Contacts

Ying Wang

CONTACT

022-23608316; wangying@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: September 23, 2026
• Study Start: September 24, 2026
• Primary Completion (Estimated): May 14, 2028
• Study Completion (Estimated): November 14, 2028
• Last Updated: September 23, 2026

Record last verified: 2026-09

Locations

CN (1)