Pilot, Prospective, Multicenter, Open and Non-randomised Study: Definition of an Index of Anti Xa Value at the End of Hemodialysis Treatment.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 11
- 主要终点
- The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
研究概览
简要总结
The current clinical study aims at defining an index of Anti Xa, which is the marker to evaluate the activity of heparin, at the end of the dialysis treatment and so showing the possibility to decrease heparin doses during hemodialysis when using Evodial hemodialyzer. Actually, an elevated value of AntiXa at the end of the dialysis treatment increases the risk of bleeding for patients with diabetic retinopathy, or for instance in case of fall at home.
详细描述
In parallel to the new hemodialyzer, Evodia blood lines were developed to improve characteristics of the extracorporeal circuit in term of reduced activation of the coagulation system and lower deposits of clot components.
The aim is to provide a system (hemodialyzer and extracorporeal circuit) with a low thrombogenicity and that can be used with low heparin dose in order to reduce the patients' bleeding risk at the end of HD treatment.
Measurements of TAT (Thrombin-Antithrombin), the marker of the activation of the coagulation, will be performed during the study in order to evaluate the thrombogenicity of the system.
The ionic clearance will be collected during all treatments to evaluate the performance of the hemodialyzer.
The study will be divided into three steps
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 suffering from chronic renal failure,
- •Patients treated in HD three times a week for at least 3 months, with a stable heparin dose and the same filter,
- •Patients treated in 4-4.5 hours HD mode with a blood flow between 300-350 ml/min,
- •Patients for whom either LMWH (Enoxaparin, Nadroparin, Tinzaparin) or UFH is used,
- •Patients with a well-functioning vascular access as judged by the investigator,
- •Patients treated either on AK, Innova or Integra dialysis machines equipped with ionic dialysance device,
- •Patients older than 18 years,
- •Patients with negative serologies (AIDS, Hepatitis)
- •Patients having signed consent to participate in the study.
排除标准
- •Patient with HIT or known heparin allergy,
- •Patient treated in HD in single needle mode,
- •Patients with catheter,
- •Patients with acute inflammatory event that may affect, as judged by investigator patients' safety or study results,
- •Patients participating in other studies that could interfere with the objective of this study,
- •Patients with active malignant disease,
- •Patients receiving heparin outside dialysis treatment,
- •Patients under guardianship,
- •Pregnant women, nursing mothers and women planning a pregnancy during the course of this study,
- •Patients with serious history of coagulopathy,
- •Patients receiving Anti-Vitamin K medication,
- •Patients receiving an association of anti platelets agents,
- •Patients with heparin dose that can not be reduced for technical reason (excluding patients receiving too low heparin dose with no possibility of further reduction).
结局指标
主要结局
The primary criterion is the measurement of Anti Xa at the end of dialysis sessions.
时间窗: End of dialysis treatment
次要结局
- Follow-up of aPTT for patients treated with UFH,(Kinetic on single dialysis treatment)
- Follow-up of ionic clearance (Diascan) measurements during HD sessions,(Kinetic of single dialysis treatment)
- Evaluation of the quality of the rinse-back (filter and circuit) via a visual scale,(End of dialysis treatment)
- Evaluation of TAT (Thrombin-Antithrombin) complex,(Kinetic on single dialysis treatment)
- Follow-up of AE/SAE.(All treatments during study period)