Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients (RHEO-PAD)

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Enrolling

Conditions

Hemodialysis

Treatments

Procedure: Rheopheresis procedure

Procedure: Shamapheresis procedure

Biological: Blood Sample

Study type

Interventional

Funder types

Other

Identifiers

NCT03975946

2018-68

RCAPHM18_0384 (Other Identifier)

2019-A01513-54 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment

260 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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. Or if revascularization has already been performed and the diagnosis of chronic critical ischemia is maintained.
Female of childbearing potential, will have to use highly effective methods of contraception from study start to the end.
Medical insurance
Signed informed consent

Exclusion criteria

Need for revascularization either endovascular (angioplasty) or surgery (bypass) of the ischemic lesion area
Pregnancy or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without contentment, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
Uncontrolled infection (persistence of fever despite appropriate antibiotic therapy)
Life expectancy greater than 1 year
Severe cognitive or psychiatric disorders
History of allergic reaction to dialysis membrane
Patients unable to give an informed consent or unwilling to participate in the study