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临床试验/NCT00695617
NCT00695617Unknown2 期

Citrate Anticoagulation During MARS Treatment

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
10
试验地点
1
主要终点
Extracorporeal circuit coagulation events

研究概览

简要总结

The optimal anticoagulation procedure during MARS treatment has not been defined. In various multi-centre trials, such as MARS-RELIEF, anticoagulation procedures are left to the discretion of the treating physician. On the one hand, given the increased risk of bleeding associated with liver failure, high dosage of anticoagulation therapy should be avoided. On the other hand, contact of blood or blood components with the extracorporeal circuit will likely result in coagulation activation or even loss of coagulation factors.

Citrate anticoagulation has gained popularity, especially in hemodialysis patients. It results in a highly effective anticoagulation, exclusively confined to the extracorporeal circulation. Moreover, dependent on the type of dialyser membrane, citrate anticoagulation resulted in reduced activation of other cellular components.

In contrast to hemodialysis patients, experience with citrate anticoagulation during treatment with artificial liver devices is limited. The liver contributes substantially to the metabolism of exogenous citrate. As a result, cirrhotic patients have decreased endogenous citrate clearances. Importantly, blood purification devices contribute substantially to overall citrate clearance, thereby preventing accumulation of citrate. Several centres, including our own, have gained experience with citrate anticoagulation during fractionated plasma separation and adsorption (FPSA), a related liver dialysis device, in the treatment of liver failure patients.

Citrate anticoagulation during MARS treatment has not been studied so far.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
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

入选标准

  • Scheduled MARS treatment
  • Age over 18 years
  • Informed consent
  • Admitted to Intensive Care Unit

排除标准

  • Blood or plasma transfusion within 48 hours before study
  • Hypocalcemia (ionised Ca < 0.90 mmol/l)
  • Acidosis (pH < 7.25) due to any cause
  • Use of citrate containing medications

研究组 & 干预措施

A

Experimental

citrate first

干预措施: trisodiumcitrate (Drug)

B

Experimental

no anticoagulation first

干预措施: trisodiumcitrate (Drug)

结局指标

主要结局

Extracorporeal circuit coagulation events

时间窗: 6 hours

次要结局

  • Citrate tolerability(6 hours)
  • Treatment efficacy(6 hours)

研究者

申办方类型
Other

研究点 (1)

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