Study Protocol: A Randomized Controlled Prospective Single-Center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT Study)

Jan-Gerd Rademacher; Björn Tampe; Angela Borisch; Rosa Marie Buschfort; Andrea von Figura; Thomas Asendorf; Peter Korsten

doi:10.3389/fmed.2022.871744

Study Protocol: A Randomized Controlled Prospective Single-Center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT Study)

Front Med (Lausanne). 2022 Apr 14:9:871744. doi: 10.3389/fmed.2022.871744. eCollection 2022.

Authors

Jan-Gerd Rademacher¹, Björn Tampe¹, Angela Borisch¹, Rosa Marie Buschfort¹, Andrea von Figura¹, Thomas Asendorf², Peter Korsten¹

Affiliations

¹ Department of Nephrology and Rheumatology, University Medical Center Göttingen, Göttingen, Germany.
² Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

Abstract

Introduction: Raynaud's phenomenon (RP) and digital ulcers (DU) are frequent manifestations of Systemic Sclerosis (SSc). Despite being very common in SSc patients, both conditions have proven to be notoriously difficult to study. There are very few available approved drugs with varying efficacy. It has been shown that the presence of DU is associated with increased whole blood viscosity (WBV). Rheopheresis (RheoP) is an extracorporeal apheresis technique used to treat microcirculatory disorders by improving blood viscosity. Improved blood flow and wound healing after RheoP treatments have been reported in single case reports.

Methods and analysis: We report the clinical trial protocol of "A randomized controlled prospective single-center feasibility study of Rheopheresis for Raynaud's syndrome and Digital Ulcers in Systemic Sclerosis (RHEACT)." RHEACT aims to investigate the efficacy of RheoP on the Raynaud Condition Score (RCS) as the primary efficacy outcome measure after 16 weeks from baseline. Thirty patients will be randomized in a 1:1:1 ratio to one of two RheoP treatment groups or assigned to the standard of care (SoC) control group (intravenous iloprost). Secondary endpoints include changes in DU, changes in nailfold video capillaroscopy and patient-reported-outcomes (Scleroderma Health Assessment Questionnaire, FACIT-Fatigue, and the Disability of Arm, Shoulder, and Hand, quick version).

Discussion: Apheresis techniques have been investigated in SSc but mainly in observational, retrospective studies, or single case reports. RheoP is a pathophysiologically driven potential new therapy for heavily burdened patients with SSc-associated secondary RP with or without DU.

Ethics and dissemination: The study was registered at clinicaltrials.gov (Identifier: NCT05204784). Furthermore, the study is made publicly available on the website of the German network of Systemic Sclerosis "Deutsches Netzwerk Systemische Sklerodermie (DNSS)."

Keywords: Raynaud’s phenomenon; blood viscosity; digital ulcers; rheopheresis; systemic sclerosis; therapeutic plasma exchange.

Associated data

ClinicalTrials.gov/NCT05204784