Rheopheresis Mechanism in Hemodialysis Patients With PAD (VALLOIRE)

May 10, 2022 updated by: University Hospital, Grenoble

Rheopheresis Mechanism of Action and Impacts on the Evolution of Peripheral Arterial Disease in Hemodialysis Patients

Peripheral arterial disease (PAD) is common in chronic hemodialysis patients (HDC) with a prevalence of 30% according to the DOPPS study.

The combination of PAD and chronic kidney disease (CKD) stage 5 is a risk factor for major amputation (24.5%) with a mortality rate of 55% at 2 years.

Ischemia occurring during PAD is the result of impaired microcirculation, with insufficient blood flow to maintain tissue perfusion and viability.

It is responsible for painful skin wounds whose healing is poor, with a significant risk of infection.

In patients with chronic renal failure, it is linked to both:

  • local phenomena (atherosclerosis, calcification)
  • changes in blood viscosity (elevated hematocrit and inflammatory proteins, especially fibrinogen)
  • a neovascularization defect (uremic toxins, in particular indoxyl sulphate). If revascularization is not possible, amputation remains the only possible treatment to relieve pain and limit the risk of infection.

Rheopheresis is an apheresis technique that allows the depletion of high molecular weight serum proteins.

This would reduce blood viscosity and red blood cell (RBC) aggregation, thereby improving microvascular perfusion, with the aim of reducing pain, improving healing and limiting the risk of amputation.

Several studies have investigated the efficacy of rheopheresis in PAD in HDC, but the level of evidence remains low.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The main objective of our study is to evaluate the impact of rheopheresis on blood (main objective) and plasma viscosity, skin microcirculation and blood coagulation (Fibrinography, Thrombin Generation).

No study has evaluated the direct effect of rheopheresis on these different parameters.

However, a better understanding of these mechanisms would make it possible both to optimize the effectiveness of the technique, to limit its potential side effects and the cost of treatment.

Study Type

Interventional

Enrollment (Anticipated)

18

Phase

  • 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 Locations

  • France
      • Grenoble, France, 38043
        • Grenoble University Hospital
        • Contact:
        • Sub-Investigator:
          • Lionel ROSTAING, MD, PhD
        • Principal Investigator:
          • Hamza NACIRI BENNANI, MD

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

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 years or more and included in the RHEOPAD protocol (2019-A01513-54)
  • ESRD treated by hemodialysis or hemodiafiltration
  • PAD-LTI with tissue loss and/or wounds (ulcers or gangrene) with at least one of the following criterion, subject to the feasibility of the measures: arterial pressure assessment at the ankle <70 mmHg, or toe pressure 30 mm Hg, or transcutaneous oximetry measurements < 40 mm Hg
  • Interventional or surgical revascularization either not technically possible or no necessary
  • Medical insurance
  • Signed informed consent

Exclusion Criteria:

  • - Uncontrolled infection despite well-conducted antibiotic therapy
  • Life expectancy < 1 year
  • Severe cognitive or psychiatric disorders
  • Pregnant woman, parturient, nursing mother
  • Patients unable to give an informed consent or unwilling to participate in the study

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: the rheopheresis group
Rheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor.
Biological: Biological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
Placebo Comparator: the shamapheresis group
Shamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor.
Biological: Biological analysis
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Blood viscosity measured by rotational rheometer
Time Frame: Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years)
To assess the effect of rheopheresis on blood viscosity of chronic hemodialysis patients with PAD
Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood viscosity measured by rotational rheometer
Time Frame: up to 24 weeks
Evaluate the effect of rheopheresis on blood viscosity measured by rotational rheometer before the 12th treatment session
up to 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the effect of rheopheresis on plasma viscosity measured by falling ball viscometer
Time Frame: Immediately before day 0 and 12-th procedure and immediately after 1st procedure
Plasma viscosity measured by falling ball viscometer in pre vs post session 1 and in pre session 12 vs baseline.
Immediately before day 0 and 12-th procedure and immediately after 1st procedure
Evaluate the effect of rheopheresis on skin microvascular function (1st and 12th sessions pre and post session)
Time Frame: Immediately before day0 and 1 years
Post-occlusive and thermal hyperaemia of cutaneous blood flow measured by speckle contrast imaging, compared between the rheopheresis and shamapheresis groups (1st and 12th sessions pre and post session)
Immediately before day0 and 1 years
Evaluate the effect of rheopheresis on coagulation
Time Frame: Immediately before day 0 and 12-th procedure and immediately after 1st procedure
Study of the lifespan of the blood clot (difference between formation time and clot lysis time) using a multi-well plate spectrophotometer (Fibrinography);
Immediately before day 0 and 12-th procedure and immediately after 1st procedure

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Collaborators

University Grenoble Alps

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 1, 2022

Primary Completion (Anticipated)

May 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

January 18, 2022

First Submitted That Met QC Criteria

May 10, 2022

First Posted (Actual)

May 13, 2022

Study Record Updates

Last Update Posted (Actual)

May 13, 2022

Last Update Submitted That Met QC Criteria

May 10, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 38RC20.461

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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