Efficacy and Tolerance of RHEOpheresis in the Treatment of Peripheral Artery Disease in Hemodialysis Patients
RHEO-PAD
3 other identifiers
interventional
260
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2019
CompletedFirst Posted
Study publicly available on registry
June 5, 2019
CompletedStudy Start
First participant enrolled
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2024
CompletedJuly 27, 2023
July 1, 2023
3.4 years
May 31, 2019
July 25, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of complete wound healing of the ischemic lesions
Complete wound healing will be assessed clinically by complete epithelialization of the ischemic lesion
8 months
Percentage of absence of major amputation.
Major amputation will be defined as above-the-knee amputation (AKAs) and below-the-knee amputation above the ankle (BKAs)
8 months
Study Arms (2)
the rheopheresis group
ACTIVE COMPARATORthe shamapheresis group
PLACEBO COMPARATORInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- The efficacy will be assessed by a vascular surgeon blinded to the study group during consultation
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2019
First Posted
June 5, 2019
Study Start
January 14, 2021
Primary Completion
June 12, 2024
Study Completion
June 12, 2024
Last Updated
July 27, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share