Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 28 March 2022
• Main ID: NCT05204784
• Date of registration: 29/11/2021
• Prospective Registration: Yes
• Primary sponsor: Peter Korsten
• Public title: Rheopheresis for Raynaud's and Digital Ulcers in Systemic Sclerosis RHEACT
• Scientific title: A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis
• Date of first enrolment: February 28, 2022
• Target sample size: 30
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT05204784
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Germany

Contacts

• Name: Peter Korsten, Dr. med.

• Name: PETER KORSTEN

• Name: Peter Korsten, Dr. med.
• Affiliation: University Medical Center Göttingen

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Raynaud Phenomenon

Scleroderma

Systemic Sclerosis

Digital Ulcer

Intervention(s)

Procedure: Rheopheresis treatment

Drug: Intravenous Infusion

Primary Outcome(s)

Raynaud Condition Score (RCS) [Time Frame: 24 weeks]

Secondary Outcome(s)

Nailfold video capillaroscopy changes [Time Frame: 24 weeks]

Whole blood viscosity [Time Frame: 24 weeks]

Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score [Time Frame: 24 weeks]

Time to healing of existing digital ulcers [Time Frame: 24 weeks]

Development of new digital ulcers [Time Frame: 24 weeks]

Quick DASH [Time Frame: 24 weeks]

Scleroderma Health Assessment Questionnaire [Time Frame: 24 weeks]

Secondary ID(s)

36/7/21

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

DiaMed GmbH