Study of Efficacy and Safety of the Plasmapheresis Method With Albumin Compensation Compared With the Plasmapheresis Method Without Albumin Compensation for Aging Biomarkers Correction in Men and Women Aged 40 to 55 Years Old

NCT04897113 | Unknown

• 1 other identifier: RU-RB-01-01-21 of 08.02.2021
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

Reaching active aging makes it important to implement new methods affecting the biological age of a person. Biochemical parameters of a blood test are aging biomarkers that are ones of the most accessible for testing. We know that, with age, there is increase in levels of LDL, triglycerides, homocysteine and other biomarkers relating the body state. Methods of extracorporeal hemocorrection showed good results in this area. For instance, the use of plasmapheresis is very effective during prophylaxis, treatment and rehabilitation after various diseases/injuries. The main effects of plasmapheresis are related to removal of endo- and exotoxins, including products of lipid peroxidation, and to draining effect as a result of a heavy flow of interstitial fluid containing products of pathometabolism into the blood stream within concentration gradient (by "dynamic equilibrium" in concentration of different substances in intracellular, interstitial and intravascular compartments). These effects are also related to release of receptors, their sensitization to their own neurohumoral regulation mechanisms, to insulin, in particular (as consequences, lower glucose tolerance, lower substrate glycation).

Conditions

Hypercholesterolemia; Hyperbilirubinemia; Hyper IgE Syndrome; Hyper Beta Lipoproteinemia; Hyper Eosinophilic Syndrome; Hyper-LDL-cholesterolemia; Gout; Diabetes; Nervous System Diseases; Neuromuscular Diseases; Cardiovascular Diseases; Urologic Diseases

Keywords

plasmapheresis; plasma exchange; albumin; biomarkers of aging; age-related diseases

Outcome Measures

Primary Outcomes (1)

• Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count

  Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count at visit 6, compared with initial values (visit 0).

  1 month

Secondary Outcomes (11)

• Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count

  17 (+/- 2) days

• Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count

  1 month

• Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test

  1 month

• Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test

  1 month

• Dynamics of results according to the method of "phenotypic age"

  1 month

Study Arms (2)

plasmapheresis with albumin compensation

EXPERIMENTAL

a course of hardware plasmapheresis procedures with replacement by colloidal (5% albumin solution) and crystalloid solutions (saline) in a ratio of 1: 3

Procedure: plasma exchange with albumin

plasmapheresis without albumin compensation

EXPERIMENTAL

a course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline).

Procedure: plasma exchange without albumin

Interventions

plasma exchange with albumin PROCEDURE

plasma exchange with albumin, two per week, 110% of the circulating plasma volume

Also known as: plasmapheresis with albumin

plasmapheresis with albumin compensation

plasma exchange without albumin PROCEDURE

plasma exchange without albumin, two per week, 110% of the circulating plasma volume

Also known as: plasmapheresis without albumin

plasmapheresis without albumin compensation

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent form.
• Men and women aged 40-55.
• Body mass index \<30 kg / m2.
• Level increase of one or several aging markers.
• Understanding of requirements for study participants, written consent to participate in the study (including volunteer's consent for his/her health information related to the study to be used and passed on) and to perform procedures outlined in study protocol.
• Negative pregnancy test for women of childbearing potential.
• Refusal to participate in the study.
• Any health conditions that, according to investigators, might prevent volunteers from participating in the study.
• Mental disorders, past medical history included.
• + alcohol units per week (one alcohol unit equals 0,5 l of beer, 200 ml of wine or 50 ml of hard liquors) or any records of alcohol addiction.
• Drug addiction, chemical abuse.
• Pregnancy or breastfeeding.
• Past medical history of severe allergic reactions.
• General contraindications to plasmapheresis procedures.
• Any other health conditions or reasons that, according to investigators, might increase risks for participants or reduce the likelihood of results needed to meet the study goals.

You may not qualify if:

• Voluntary refusal to participate in the study.
• Participant refuses to cooperate with investigator or is undisciplined.
• In case participant misses one or several study procedures or follow-up visits.
• Development of severe adverse reactions or severe diseases/conditions unrelated to the study, requiring withdrawal from therapy.
• Positive pregnancy test.

Sponsors & Collaborators

• National Medical Research Center for Rehabilitation and Balneology: lead
• The Orenburg Regional Clinical Hospital: collaborator
• DNKOM LLC: collaborator
• Pirogov Russian National Research Medical University: collaborator

Study Sites (2)

Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia

Moscow, 121099, Russia

RECRUITING

Orenburg regional clinical blood transfusion station

Orenburg, 460018, Russia

RECRUITING

MeSH Terms

Conditions

Hypercholesterolemia; Hyperbilirubinemia; Job Syndrome; Hyperlipoproteinemia Type II; Hypereosinophilic Syndrome; Gout; Diabetes Mellitus; Nervous System Diseases; Neuromuscular Diseases; Cardiovascular Diseases; Urologic Diseases

Interventions

Plasma Exchange; Albumins; Plasmapheresis

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phagocyte Bactericidal Dysfunction; Leukocyte Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Hyperlipoproteinemias; Eosinophilia; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Glucose Metabolism Disorders; Endocrine System Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Ilmira Gilmutdinova

  Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia

  STUDY CHAIR

Central Study Contacts

Ilmira Gilmutdinova

CONTACT

+79686861979; gilm.ilmira@mail.ru

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: May 18, 2021
• First Posted: May 21, 2021
• Study Start: May 12, 2021
• Primary Completion: October 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 21, 2021

Record last verified: 2021-05

Locations

RU (2)