EXPLORING THE MODULATORY EFFECT OF THE DIALYZER MEMBRANE CHOICE ON HEMODIALYSIS ASSOCIATED THROMBOINFLAMMATION: A PROSPECTIVE RANDOMIZED CROSSOVER TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
研究概览
简要总结
This clinical trial investigates whether the dialyzer membrane influences hemodialysis-associated thromboinflammation. Specifically, it evaluates the effects of 3 commercially available dialyzer membrane types on immune cell activation and thromboinflammatory responses.
During this trial, participants will undergo standard hemodialysis (3 sessions/week, 4 hours each) and receive three different dialyzer membranes in a crossover design, one for each session with a total study duration of 1 week.
During each session blood samples will be collected (at baseline, hourly, and at the end of dialysis) and additionally, after each session, the used dialysis circuit will be rinsed to recover adherent cells.
The study aims to:
- Assess whether the dialyzer membrane influences leukocyte and platelet activation .
- Evaluate whether the dialyzer membrane influences neutrophil extracellular trap (NET) formation.
- Evaluate whether the dialyzer membrane influences the transcriptomic profiles of immune cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Dialysis vintage ≥ 3 months
- •Treatment schedule of 3x4 hours weekly
- •well functioning dual lumen vascular access
- •Treatment with ASA 80-100mg daily
- •Patients able and agree to provide signed informed consent
排除标准
- •Known vascular access dysfunction defined by FOR CATHETER ACCESS: high dose urokinase use within 4 weeks prior to study participation, planned catheter opacification, Qb <250mL/min within the 2 weeks prior to study participation FOR AV ACCESS: planned AV access intervention, recent AV access intervention within 4 weeks prior to study participation, known AV access dysfunction
- •Known active malignancy and/or active autoimmune disease
- •Known clotting/bleeding disorders
- •Current treatment with immunosuppressive medication
- •Current treatment with P2Y12 receptor antagonists (including clopidogrel, prasugrel, ticlodipine, cangrelor, ticagrelor), epoprostenol and glycoproteine IIb/IIIa receptor antagonists (tirofiban)
- •Current treatment with oral anticoagulation maintenance therapy, including vitamin K antagonists or direct oral anticoagulants
- •Current treatment with low molecular weight heparins (LMWH), heparinoids, bivalirudin, fondaparinux, protein C, or antithrombin.
- •Active infection and/or ongoing systemic antimicrobial treatment.
- •Hospitalized patients
- •Patients treated with heparin-free hemodialysis
- •Recent (<1 week) platelet transfusion or packed cells transfusion
- •Patients receiving intradialytic TPN
- •Patients requiring intravenous iron administration during dialysis (EPO or Parsabiv administration will be postponed until after disconnection from the dialysis circuit and after T240 blood sampling).
- •Patients with cytopenia affecting either white blood cells (WBC < 4x10³/mm³) or platelets defined as (platelet counts <100x10³/mm³)
- •Patients known to have had allergic reactions to PS, PMMA or ATA dialyzer
结局指标
主要结局
Differences in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuit in relation to the dialysate composition
时间窗: Over the course of 1 week (3 hemodialysis sessions)
The primary endpoint will be the difference in leukocyte and platelet counts in rinse fluids of discarded hemodialysis circuits in relation to the dialyzer membrane used.
次要结局
- Differences in leukocyte and platelet activation markers in blood and rinse fluid samples of discarded hemodialysis circuits measured by flow cytometry in relation to dialysate composition(over the course of 1 week (3 hemodialysis sessions))
- Differences in coagulation activation and inflammatory markers measured by multiplex-based immunoassays in relation to dialysate composition(Over the course of 1 week (3 hemodialysis sessions))
- Differences in Neutrophil Extracellular Trap (NET) formation in relation to the dialysate composition(Over the course of 1 week (3 hemodialysis sessions))