Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients

  • STATUS
    Recruiting
  • End date
    Jun 12, 2024
  • participants needed
    260
  • sponsor
    Assistance Publique Hopitaux De Marseille
Updated on 25 January 2021
renal failure
hemodiafiltration
nephropathy
gangrene
conservative treatments

Summary

Peripheral arterial disease (PAD) with limb-threatening ischemia (PAD-LTI) involves both macrocirculation and microcirculation. Macrocirculatory abnormalities are accessible to revascularization techniques (endovascular or surgical) contrary to microcirculatory abnormalities. Conservative treatments have limited efficacy in patients with end-stage renal disease (ESRD). There is no alternative treatment for patients with PAD-LTI in hemodialysis.

Rheopheresis is an apheresis technique specifically designed for the treatment of microcirculatory disorders in which anomalies of rheology are at the center of physiopathology. This double cascade plasma filtration technique reduces plasma viscosity and eliminates inflammation mediators which play an essential role in PAD. This technique has already shown its effectiveness in a randomized trial in dry Age-related macular degeneration (AMD), another pathology of microcirculation. The effectiveness of rheopheresis in PAD-LTI has only been reported in a small number of cases.

This Hypothesis is that the treatment of microcirculation by rheopheresis would improve wound healing of the ischemic lesion and/or reduce major amputation and thus the prognosis of the affected limb of the patient with PAD-LTI in hemodialysis. This objective is to demonstrate the efficacy of rheopheresis, (twelve sessions), to avoid major amputation and reaches complete wound healing of ischemic lesion in the dialysis patient population with PAD-LTI. This study is prospective, Controlled, Parallel, Randomized, Single blind and Multicentric in France (12 French centers).

Details
Condition Hemodialysis, Hemodialysis
Treatment Blood sample, Rheopheresis procedure, Shamapheresis procedure
Clinical Study IdentifierNCT03975946
SponsorAssistance Publique Hopitaux De Marseille
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 18 years or more
End stage renal disease (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: arterial pressure assessment at the ankle <70 millimeter of mercury (mmHg), or toe pressure 30 mmHg, or transcutaneous oximetry measurements < 40 mmHg
Interventional or surgical revascularization either not technically possible or no necessary - Medical insurance - Signed informed consent

Exclusion Criteria

Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area
Pregnancy or breastfeeding
Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy) - Life expectancy greater than 1 year - Severe cognitive or psychiatric disorders
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