Evaluation of Contact Phase Activation During Hemodialysis Using Different Dialysis Membranes: a Prospective Randomized Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
研究概览
简要总结
Every patient included in the study will undergo 3 standardised hemodialysis treatments, each using a different dialysis membrane (PMMA, PS, AN69ST). The order of the membranes used will be randomized.
During each conventional and standardised hemodialysis treatment, 6 blood samples will be taken at different time points (T0, T5, T15, T30, T90, T240) to evaluate coagulation activation (TAT, PF1+2, d-dimers, TF) and, more specifically, activation of the contact phase pathway of coagulation (kallikrein, fXIa, fXIIa).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients treated with hemodialysis since at least three months.
- •Hemodialysis treatment schedule of 3 x 4 hours weekly.
- •Arteriovenous fistula (AVF) use for vascular access.
- •Treatment with oral acetylsalicylic acid 80 or 100mg q every day.
- •≥ 18 years of age.
- •Patients able and agree to provide signed informed consent.
排除标准
- •Use of vitamin K antagonists or novel oral anticoagulant therapy.
- •Use of chronic heparin treatment, UFH or LMWH.
- •Use of clopidogrel.
- •Use of ACE-inhibitors.
- •Known allergy against one of the dialysis membranes used during this study (PMMA: BKU®, Toray; PS: Phylter®, Bellco; AN69ST: Evodial®, Gambro).
- •Known heparin-induced trombopenia type
- •Active infection and/or ongoing systemic antimicrobial treatment.
- •Presence of central venous catheter, tunnelled or non-tunnelled and/or AV graft.
- •Hospitalized patients.
- •Planned surgery during study period.
- •Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
- •Vascular access dysfunction defined as (a) known AV access outflow tract stenosis, (b) planned vascular access intervention, (c) planned vascular access conversion.
- •Planned conversion of dialysis modality during study period.
研究组 & 干预措施
PMMA (BKU)
Patients included in the study will undergo 3 hemodialysis treatments. During the PMMA Arm, patient will be dialyzed using a BKU 1.6 (Toray) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
During each study treatment, blood samples will be taken at specified time points (T0, T5, T15, T30, T90, T240) to assess overall coagulation activation (TAT, PF1+2, d-dimers), contact phase activation (kallikrein, fXIa, fXIIa), and activation of the extrinsic coagulation pathway (TF).
干预措施: PMMA (BKU) (Device)
PS (Phylter)
Patients included in the study will undergo 3 hemodialysis treatments. During the PS Arm, patient will be dialyzed using a Phylter 1.7 (Bellco) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
干预措施: PS (Phylter) (Device)
AN69ST (Evodial)
Patients included in the study will undergo 3 hemodialysis treatments. During the AN69ST Arm, patient will be dialyzed using a Evodial 1.6 (Gambro) dialyzer. All study treatments will be standardized for dialysis access, priming procedure, blood and dialysate flows, anticoagulation therapy and duration of the hemodialysis session.
干预措施: AN69ST (Evodial) (Device)
结局指标
主要结局
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIIa.
时间窗: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
ELISA testing for plasma fXIIa (pg/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma kallikrein.
时间窗: Blood samples are taken before hemodialysis treatment start and 5minutes (min), 15min, 30min, 90min and 240min after hemodialysis treatment start.
ELISA testing for plasma kallikrein (pg/mL).
Change in contact phase activation induced by hemodialysis treatment, assessed by measurement of plasma fXIa.
时间窗: Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.
Chromogenic test for plasma fXIa (mIU/mL).
次要结局
- Change in extrinsic coagulation activation during hemodialysis treatment assessed by measurement of plasma Tissue Factor(Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)
- Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma TAT.(Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)
- Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma PF1+2.(Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)
- Change in overall coagulation activation induced by hemodialysis treatment, assessed by measurement of plasma d-dimers.(Blood samples are taken before hemodialysis treatment start and 5min, 15min, 30min, 90min and 240min after hemodialysis treatment start.)
研究者
Karlien François
MD
Universitair Ziekenhuis Brussel