Rheopheresis Mechanism in Hemodialysis Patients With PAD (VALLOIRE)

Grenoble Alpes University Hospital Center (CHU)

Status: Unknown

Conditions: Hemodialysis

Treatments: Biological: Biological analysis

Study type: Interventional

Funder types: Other

Identifiers

NCT05373524

38RC20.461

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

the rheopheresis group

Active Comparator group

Description:

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.

Treatment:

Biological: Biological analysis

the shamapheresis group

Placebo Comparator group

Description:

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.

Treatment:

Biological: Biological analysis