Informations générales (source: ClinicalTrials.gov)
Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial (RHEO-PAD)
Interventional
N/A
Assistance Publique Hopitaux De Marseille (Voir sur ClinicalTrials)
janvier 2021
juin 2024
29 juin 2024
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).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | MONTSENY | 14/02/2025 09:03:19 | Contacter | ||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Assistance Publique Hôpitaux de Marseille - 13354 - Marseille - France | Thomas ROBERT, PH | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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