Status:
UNKNOWN
Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis
Lead Sponsor:
Peter Korsten
Collaborating Sponsors:
DiaMed GmbH
Conditions:
Systemic Sclerosis
Raynaud Phenomenon
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 o...
Eligibility Criteria
Inclusion
- Adult patients fulfilling ACR/EULAR classification criteria for SSc
- Presence of RP with or without DU
- Failure of at least one standard of care treatment (CCB or iloprost) for at least three months
- RCS \> 4
- Possibility to obtain venous access (either through a peripherally or centrally inserted catheter)
Exclusion
- Significant anemia (\<8 g/dL)
- Clinically relevant hemorrhagic diathesis or coagulopathy
- Diabetes mellitus
- Serious acute or chronic kidney (eGFR\<30 ml/min/1.73m2) or liver failure
- Hypotension with systolic blood pressure \<100 mmHg
- Chronic viral infections (HIV, Hepatitis B, C)
- Epilepsia, psychosis, dementia, or other relevant neurologic condition precluding the conduct of plasmapheresis
- Malignant disease or any other condition with life expectancy \<12 months
- Known history of alcohol or drug abuse
- Long-term serious tobacco abuse with documented severe vascular disease (Fontaine \>III).
- Severe hyperlipoproteinemia, defined as a significant elevation of Lp(a) or LDL cholesterol despite standard doses of medical therapy
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05204784
Start Date
February 28 2022
End Date
June 1 2024
Last Update
March 23 2022
Active Locations (1)
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1
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany, 37075