[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"plasma-exchange\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:plasma-exchange":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100657214","human-albumin-combined-with-plasma-exchange-for-frailty-intervention-100657214",false,"NCT07836127","Human Albumin Combined With Plasma Exchange for Frailty Intervention","A Prospective, Randomized Exploratory Study on the Intervention of Frailty With Human Albumin Combined With Plasma Exchange","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Clear consciousness and ability to communicate.\n3. Sufficient cognitive function and educational level to complete all study-related assessments.\n4. A score of ≥ 1 on the FRAIL scale.\n5. Voluntary written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or hypersensitivity to albumin (ALB) or intravenous immunoglobulin (IVIg).\n2. Currently receiving albumin (ALB) and\u002For intravenous immunoglobulin (IVIg) infusion for other reasons.\n3. Severe cardiac, hepatic, or renal insufficiency.\n4. Active infection or acute exacerbation of chronic infection.\n5. Current use of direct oral anticoagulants (DOACs).\n6. History of bleeding disorders or coagulation dysfunction.\n7. Concomitant malignancy or expected survival of less than 6 months.\n8. Severe visual, auditory, or motor function impairment.\n9. Refusal to sign the informed consent form.\n10. Other conditions that, in the opinion of the investigator, make the participant unsuitable for the study.","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27],"Frailty","Plasma Exchange","NOT_YET_RECRUITING","2026-09-18",{"date":31,"type":32},"2026-09-23","ACTUAL",{"date":34,"type":20},"2026-09-24",{"date":36,"type":20},"2028-11-14",{"name":38,"class":39},"Institute of Hematology & Blood Diseases Hospital, China","OTHER"]