Heparin-Free Chronic HemoDialysis Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week
研究概览
简要总结
Intermittent hemodialysis is a complex technique which requires careful monitoring of anticoagulation levels to prevent clotting and reduce the risk of bleeding complications. Dialysis patients often exhibit hypercoagulable tendencies due to uremic state, turbulent blood flows in dialysis procedures, and thrombogenic exposure to artificial surfaces of dialysis tubing. Patients with ESRD may experience both dialyzer clotting and excessive bleeding, so individualized heparin dosing and periodic adjustments are necessary to ensure adequate anticoagulation during hemodialysis. The ideal anticoagulant should prevent thrombosis while minimizing the risk of intra- and interdialytic bleeding. The use of heparin carries risks such as worsening of osteoporosis and dyslipidemia, allergic reactions like pruritus, and the potential for life-threatening heparin-induced thrombocytopenia (HIT) for which avoidance of heparin is necessary during dialysis.Heparin, in both its unfractionated heparin (UFH) and low molecular weight heparin (LMWH) forms, is the most commonly used anticoagulant, though evidence comparing their efficacy and risk of bleeding remains inconclusive. End-stage renal disease (ESRD) patients, who are already at higher risk of serious bleeding, may benefit from regional anticoagulation (RA) techniques, as they typically receive around 600,000 IU of heparin per year. The investigators performed routinely a simplified regional anticoagulation procedure (RAP) using a constant calcium re-injection rate over the time to avoid hypocalcemia. This procedure eliminates the need for citrate infusion and calcium monitoring, and reduces nurse workload in a chronic dialysis unit. The investigators compared 21 chronic dialysis patients with 198 RA and 195 heparin sessions, where each patient acted as their own control. None of them were on VKA during the RA sessions, 62% were on single anti-platelet therapy and 14% were on dual anti-platelet therapy. The dialysis session success rate was 94% in the RA group and 97% in the heparin group, with no significant differences (p=0.22). The circuit loss rate was 1.5% per RA session and 0.5% per heparin session (p=0.23), and the early blood restitution rate was 3% and 1.5% (p=0.50) in the RA and heparin groups, respectively
Hypothesis: RAP can be as effective as systemic anticoagulation with heparin for intermittent dialysis in chronic hemodialysis patients, with the potential to reduce the rate of hemorrhagic events
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Man or woman aged 18 years or more
- •Patients with end-stage renal disease (ESRD) under intermittent hemodialysis, for more than 3 months prior to screening and with a dialysis duration prescription of at least 4 hours
- •Effective anticoagulation either by UFH or by LMWH of the dialysis session defined by the absence of circuit loss in the last 3 months.
- •Dialysis adequacy defined by a mean Kt/V ≥1.
- •Calcemia within the normal range at inclusion (2.2 to 2.6 mmol/L) (based on the results of the last monthly blood test)
- •Subject affiliated to or beneficiary of a social security system.
- •Subject having signed written informed consent.
排除标准
- •Dysfunctional vascular access at the screening
- •Unipunction of the AVF
- •Patient treated by hemofiltration or hemodiafiltration procedure
- •Current anticoagulation treatment
- •Patient treated by digitalizing drugs
- •Patient treated by thiazide diuretics
- •Patient with hypercalcemia and/or hypercalciuria
- •History of sensitivity to heparin or heparin-induced thrombocytopenia.
- •Active hemorrhage
- •High bleeding risk defined by the following situations: recent bleeding of less than 7 days, recent post-operative period of less than 7 days, recent head trauma of less than 7 days, recent ischemic stroke of less than 7 days, uremic pericarditis.
- •Body weight < 45 kg and > 140 kg at screening.
- •Known allergy to citrate
- •Hospitalization at the screening for all other causes apart from dialysis
- •Moribund status (defined by the expectation of death in less than three months).
- •Liver failure (to prevent citrate liver toxicity) based on the results of the last monthly or quarterly blood test
- •Ongoing participation in a concurrent interventional study in dialysis or with anti-coagulation therapy
- •Pregnancy (declarative) or breastfeeding and all the other categories of people with special protection according to the French Code de la Santé Publique (CSP): patients under legal supervision, patients hospitalized without consent, patients admitted in social or sanitary structures for care and not research, and patients in emergency situations
- •Patients unable to give an informed consent or unwilling to participate in the study.
- •Heparin-coated membrane in current dialysis prescription
结局指标
主要结局
Demonstrate the non-inferiority of the regional anticoagulation procedure compared to heparin anticoagulation on the dialysis sessions success three times per week
时间窗: 6 months
The primary endpoint will be the rate of dialysis sessions success over 6 months between two therapeutic strategies: * Regional anticoagulation procedure (RAP) * Heparin anticoagulation
次要结局
- Compare between the groups clinical Impact at each dialyses session on fistula compression time extended more than 10 minutes(6 months)
- Compare between the groups clinical Impact during the total duration of the study on dialysis adequacy(6 months)
- Compare between the groups clinical Impact during the total duration of the study on incidence of cardiovascular-related mortality and major cardiovascular events (MACE)(6 months)
- Compare between the groups clinical Impact during the total duration of the study on incidence of non-hemorrhagic heparin-related complications(6 months)
- Compare between the groups the tolerance of adverse events(6 months)
- Compare between the groups clinical Impact at each dialyses session on early bypass restitution(6 months)
- Compare between the groups clinical Impact during the total duration of the study on relative effects on phosphocalcic balance(6 months)
- Compare between the groups clinical Impact during the total duration of the study on global mortality(6 months)
- Compare between the groups the tolerance of per-dialytic hypotension(6 months)
- Compare between the groups clinical Impact at each dialyses session on bypass loss(6 months)
- Compare between the groups clinical Impact at each dialyses session on dialysis duration(6 months)
- Compare between the groups clinical Impact during the total duration of the study on incidence of hemorrhagic events(6 months)
- Compare between the groups clinical Impact during the total duration of the study on incidence of Hyperparthyroidism(6 months)