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Retrospective Study Evaluating the Contribution of Rheopheresis in the Treatment of Uremic Calciphylaxis (RHEO-CUA)

NCT ID: NCT05633121

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-20

Study Completion Date

2023-09-30

Brief Summary

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Calcifying uremic arteriolopathy (or uremic calciphylaxis) is a rare disease (prevalence \<1% of dialysis patients), but the prognosis is often catastrophic. The main non-modifiable risk factors are age, female gender, diabetes, obesity and length of time on dialysis. Today, there is no specific treatment for this pathology, and the therapeutic management is poorly codified. However, it is commonly accepted that the treatment is based on the control of risk factors, local care, and the possible addition of treatment with sodium thiosulfate. Hyperbaric oxygen therapy has also been proposed by some authors, but remains not very accessible in practice.

Recently, it has been proposed to use Rheopheresis as an adjuvant treatment for severe forms of uraemic calciphylaxis. It is a technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. The expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications.

The aim of this study is to propose a large national retrospective study, studying the evolution of patients with uremic calciphylaxis and treated by rheopheresis, compared to a control group. This will allow to have a more precise idea of the contribution of Rheopheresis in this indication.

Detailed Description

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Conditions

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Rheopheresis Calcifying Uremic Arteriolopathy Uremic Calciphylaxis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient suffering from uremic calciphylaxis treated with rheopheresis

Rheopheresis

Intervention Type PROCEDURE

Technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. The expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications.

Patient suffering from uremic calciphylaxis not treated with rheopheresis

No interventions assigned to this group

Interventions

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Rheopheresis

Technique of apheresis in double filtration, allowing the extraction of molecules of high molecular weight, and thus the improvement of the rheological conditions of microcirculation. The expected effect is the improvement of tissue oxygenation and the acceleration of the healing of skin lesions, with the consequent reduction of infectious complications.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Adult patient
* Chronic hemodialysis
* Uraemic calciphylaxis (clinical or histological diagnosis) diagnosed between January 2010 and December 2022,
* Rheopheresis treatment initiated within one month of calciphylaxis diagnosis (for the exposed group)
* Patient informed and not opposed to the use of their health data.

Exclusion Criteria

* minor patient,
* Advanced cognitive disorders.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Elsan

OTHER

Sponsor Role collaborator

Association ECHO

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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ECHO - Pole Santé Sud

Le Mans, , France

Site Status

Countries

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France

Other Identifiers

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RHEO-CUA

Identifier Type: -

Identifier Source: org_study_id