A Randomized Controlled Prospective Single-center Feasibility Study of Rheopheresis for Raynaud's Syndrome and Digital Ulcers in Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Raynaud Condition Score (RCS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Possibility to obtain venous access (either through a peripherally or centrally inserted catheter)
排除标准
- •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
研究组 & 干预措施
Arm 1
2 Rheopheresis treatments per week x 2, followed by 8 weeks without treatment, 8 overall treatments
干预措施: Rheopheresis treatment (Procedure)
Arm 2
2 Rheopheresis treatments in week 1, followed by 1 treatment every 2 weeks, 8 overall treatments
干预措施: Rheopheresis treatment (Procedure)
Control Group
Standard of care treatment with intravenous iloprost
干预措施: Intravenous Infusion (Drug)
结局指标
主要结局
Raynaud Condition Score (RCS)
时间窗: 24 weeks
changes of the Raynaud Condition after treatment, higher RCS denotes worse clinical findings
次要结局
- Time to healing of existing digital ulcers(24 weeks)
- Scleroderma Health Assessment Questionnaire(24 weeks)
- Whole blood viscosity(24 weeks)
- Development of new digital ulcers(24 weeks)
- Quick DASH(24 weeks)
- Nailfold video capillaroscopy changes(24 weeks)
- Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score(24 weeks)