NCT05204784

Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Peter Korsten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this feasibility study, we aim to explore therapeutic Rheopheresis (RheoP) as a novel treatment option for SSc-associated Raynaud's phenomenon and/or digital ulcers and compare it to the standard of care treatment (intravenous iloprost. RheoP has been used for RP/DU with some success in observational studies, nevertheless, the optimal treatment modality, duration, or frequency of RheoP (and PEX in general) in SSc has not been established as of yet.

Conditions

• Systemic Sclerosis
• Raynaud Phenomenon
• Digital Ulcer
• Scleroderma

Interventions

Type	Name	Description
PROCEDURE	Rheopheresis treatment	After obtaining venous access, anticoagulated blood is pumped through a plasmafilter. The plasma is then run through the Rheofilter and large plasma proteins are removed. Finally, cells are reinfused, and blood is returned to the patient.
DRUG	Intravenous Infusion	Standard of care treatment consists of intravenous iloprost infusions at a dose of 0.5-2 ng/kg/min administered over at least 6 hours as per local standard

Timeline

• Start date: 2022-02-28
• Primary completion: 2023-12-01
• Completion: 2024-06-01
• First posted: 2022-01-24
• Last updated: 2022-03-23

Locations

1 site across 1 country: Germany