Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

Launched by PETER KORSTEN · Jan 10, 2022

Keywords

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Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients fulfilling ACR/EULAR classification criteria for SSc
• • 2. Presence of RP with or without DU
• • 3. Failure of at least one standard of care treatment (CCB or iloprost) for at least three months
• • 4. RCS \> 4
• • 5. Possibility to obtain venous access (either through a peripherally or centrally inserted catheter)
• Exclusion Criteria:
• • 1. Significant anemia (\<8 g/dL)
• • 2. Clinically relevant hemorrhagic diathesis or coagulopathy
• • 3. Diabetes mellitus
• • 4. Serious acute or chronic kidney (eGFR\<30 ml/min/1.73m2) or liver failure
• • 5. Hypotension with systolic blood pressure \<100 mmHg
• • 6. Chronic viral infections (HIV, Hepatitis B, C)
• • 7. Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the conduct of plasmapheresis
• • 8. Malignant disease or any other condition with life expectancy \<12 months
• • 9. Known history of alcohol or drug abuse
• • 10. Long-term serious tobacco abuse with documented severe vascular disease (Fontaine \>III).
• • 11. Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL cholesterol despite standard doses of medical therapy