Evaluation of Systemic Leakage When a Heparin or Citrate Lock is Injected and Biological and Clinical Repercussions: Ancillary Study of the VERROU-REA Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Level of calcaemia
研究概览
简要总结
In the VERROUREA study, there were two cases of an abnormal increase in TCA. In theory no leakage of the lock into the bloodstream should have been seen. Lock leakage could have particularly serious, and especially clinical, repercussions in these patients who already have a high risk of haemorrhage given the numerous associated comorbidities. The aim of this study is to investigate the leakage of locks into the bloodstream by measuring, before and after injection of the lock, the evolution of haemostasis tests and calcaemia. The findings will complete safety data already collected in the VERROU REA study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
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
- •Patient aged > 18 years
- •Requiring dialysis for acute kidney failure
- •In whom a first non-tunnelled catheter has been inserted
- •In the jugular or femoral position
- •Once informed consent has been obtained from the patient, a family member or a person of trust
排除标准
- •Patients with active and poorly-controlled bleeding
- •Known allergy to citrate
- •Liver failure (Factor V <30%)
- •Thrombopenia < 30 000/mm3 in the absence of planned corrective measures at the time of randomization
- •Known or suspected heparin-induced thrombopenia
- •Positive blood cultures without treatment or with inappropriate treatment at the time of randomization
- •Catheter inserted in the subclavian position
- •Person without national health insurance cover
- •Pregnant women
- •Adults under guardianship
研究组 & 干预措施
Citrate lock
干预措施: citrate 4% (Drug)
Citrate lock
干预措施: blood sample (Biological)
Heparin lock
干预措施: unfractionated heparin (Drug)
Heparin lock
干预措施: blood sample (Biological)
结局指标
主要结局
Level of calcaemia
时间窗: through study completion an average of 28 days
Level of haemostasis
时间窗: through study completion an average of 28 days
次要结局
未报告次要终点