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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
Rheopheresis using plasma separation and plasma filtration, coupled to hemodialysis
Grenoble University Hospital
Grenoble, France
Change in Blood viscosity measured by rotational rheometer
To assess the effect of rheopheresis on blood viscosity of chronic hemodialysis patients with PAD
Time frame: Immediately before 1ST and immediately after 12th procedure , outcome measurement will be reported at the end of the study (approximately 3 years)
Blood viscosity measured by rotational rheometer
Evaluate the effect of rheopheresis on blood viscosity measured by rotational rheometer before the 12th treatment session
Time frame: up to 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.