Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients (RHEO-PAD)
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|ClinicalTrials.gov Identifier: NCT03975946|
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 19, 2020
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).
|Condition or disease||Intervention/treatment||Phase|
|Hemodialysis||Procedure: Rheopheresis procedure Biological: Blood Sample Procedure: Shamapheresis procedure||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation|
|Official Title:||Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients: a Prospective Randomized Single-blind Trial|
|Actual Study Start Date :||June 12, 2020|
|Estimated Primary Completion Date :||June 12, 2024|
|Estimated Study Completion Date :||June 12, 2024|
|Active Comparator: the rheopheresis group||
Procedure: Rheopheresis procedure
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.
Biological: Blood Sample
|Placebo Comparator: the shamapheresis group||
Biological: Blood Sample
Procedure: Shamapheresis procedure
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.
- Percentage of complete wound healing of the ischemic lesions [ Time Frame: 8 months ]Complete wound healing will be assessed clinically by complete epithelialization of the ischemic lesion
- Percentage of absence of major amputation. [ Time Frame: 8 months ]Major amputation will be defined as above-the-knee amputation (AKAs) and below-the-knee amputation above the ankle (BKAs)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975946
|Contact: Thomas ROBERT, PH||491384095 ext +firstname.lastname@example.org|
|Contact: Jean-Olivier ARNAUD, Director||491382747 ext +email@example.com|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Thomas ROBERT, PH 491384095 ext +33 firstname.lastname@example.org|
|Contact: Jean-Olivier ARNAUD, Director 491382747 ext +33 email@example.com|
|Principal Investigator: Thomas ROBERT, PH|