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

May 18, 2021 updated by: National Medical Research Center for Rehabilitation and Balneology

Multicenter, Open, Prospective, Randomized Trial 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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

One of the initial approaches of anti-ageing therapy is detoxification, reocorrection and immunocorrection. 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).

Thus, at this stage, experts assess effectiveness and organize data of existing prevention methods for premature aging and correction of aging biomarkers, as well as develop comprehensive programs for drug-free and pharmacological intervention. Introduction of the body detoxification method based on extracorporeal hemocorrection (developed in FGBU Russian Scientific Center for Medical Rehabilitation and Balneology of Ministry of Health of Russian Federation) may extend the range of effective and safe methods within such programs, as well as lower patients' biological age and, thus, lower risks of developing age-related diseases, decrease number of disability cases, which can contribute to life prolonging and improvement of its quality.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 121099
        • Recruiting
        • Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia
        • Contact:
      • Orenburg, Russian Federation, 460018
        • Recruiting
        • Orenburg regional clinical blood transfusion station
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Non-inclusion Criteria:

  • 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.
  • 10 + 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.

Exclusion Criteria:

  • Voluntary refusal to participate in the study.
  • Investigator doctor's decision on participant's exclusion for this participant's own benefit.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: plasmapheresis with albumin compensation
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
plasma exchange with albumin, two per week, 110% of the circulating plasma volume
Other Names:
  • plasmapheresis with albumin
Experimental: plasmapheresis without albumin compensation
a course of hardware plasmapheresis procedures without replacement by albumin solution, only crystalloid solutions (saline).
Procedure: plasma exchange without albumin
plasma exchange without albumin, two per week, 110% of the circulating plasma volume
Other Names:
  • plasmapheresis without albumin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Time Frame: 1 month
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dynamics summary for improvement of aging biomarkers' values assessed by a patient's biochemical blood count
Time Frame: 17 (+/- 2) days
Dynamics summary for aging biomarkers' values assessed by a patient's biochemical blood count at visit 5, compared with initial values (visit 0).
17 (+/- 2) days
Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count
Time Frame: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's complete blood count at visits 5 and 6, compared with initial values (visit 0).
1 month
Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test
Time Frame: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's blood serological test at visits 5 and 6, compared with initial values (visit 0).
1 month
Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test
Time Frame: 1 month
Dynamics summary for aging biomarkers' values assessed by a patient's coagulation test at visits 5 and 6, compared with initial values (visit 0).
1 month
Dynamics of results according to the method of "phenotypic age"
Time Frame: 1 month

Dynamics of results according to the method of "phenotypic age" assessment with the use of values of complete and biochemical blood counts at visits 5 and 6, compared with initial values (visit 0).

An assessment of the "phenotypic age" will be carried out (Morgan E. et al., 2018). For counting, 10 markers are used: albumin, creatinine, glucose, C-reactive protein, percentage of lymphocytes, average cell volume, distribution width of erythrocytes, alkaline phosphatase, leukocyte count, chronological age.
1 month
Dynamics of results according to the method of biological age
Time Frame: 1 month

Dynamics of results according to the method of biological age assessment with the use of values of complete and biochemical blood counts at visits 5 and 6, compared with initial values (visit 0). The biological age will be assessed by the method of Putin E., Mamoshina P. et al., 2016. The following markers are used for calculation by this method: albumin, glucose, urea, cholesterol, total protein, sodium, creatinine, hemoglobin, total bilirubin, triglycerides , HDL cholesterol, LDL cholesterol (Friedewald), calcium, potassium, hematocrit, MCHC, MCV, platelets, erythrocytes (erythrocytes), weight, height.

An online system available at http://www.aging.ai will be used to estimate biological age.
1 month
Dynamic pattern according to ECG results
Time Frame: 1 month
Dynamic pattern according to ECG results in 12 leads at visits 5 and 6, compared with initial values (visit 0).
1 month
Dynamic pattern according to results of vascular ultrasonography
Time Frame: 1 month
Dynamic pattern according to results of vascular ultrasonography at visits 5 and 6, compared with initial values (visit 0).
1 month
SF-36 scale
Time Frame: 1 month
Change of scores according to every scale out of all 8 scales from the SF-36 questionnaire at visits 5, 6 and 7, compared with initial values (visit 0).
1 month
HAM questionnaire
Time Frame: 1 month
Dynamics of subjective assessment of a patient's current psycho emotional state (HAM questionnaire) at visits 5, 6 and 7, compared with initial values (visit 0). The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), abbreviated HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery.
1 month
scales of the "Health-Promoting Lifestyle Profile"
Time Frame: 1 month
Change of scores according to every scale out of 6 scales of the "Health-Promoting Lifestyle Profile" questionnaire at visits 5, 6 and 7, compared with initial values (visit 0).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Medical Research Center for Rehabilitation and Balneology

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pirogov Russian National Research Medical University
DNKOM LLC
The Orenburg Regional Clinical Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ilmira Gilmutdinova, Federal State Budgetary Institution "National Medical Center for Rehabilitation and Balneology" of the Ministry of Health of Russia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 12, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RU-RB-01-01-21 of 08.02.2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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