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临床试验/NCT05191290
NCT05191290已完成4 期

Comparison of Biocompatibility of Plasmapheresis Procedures With Citrate and Heparin Anticoagulation

University Medical Centre Ljubljana1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年1月21日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
15
试验地点
1
主要终点
change in serum platelet factor 4 from baseline to the end of plasmapheresis

研究概览

简要总结

Membrane plasmapheresis is one of the methods for treating immune diseases. Plasmapheresis removes autoantibodies and immune complexes, paraproteins, lipoproteins and reduces the concentration of cytokines. In membrane plasmapheresis, plasma is separated from blood cells by a highly permeable membrane. The filtered plasma is then discarded and replaced with replacement fluid. During the procedure, there is an activation of the coagulation system, because of the extracorporeal blood circulation. The anticoagulation during the procedure is therefore necessary.

详细描述

Standard heparin or citrate is routinely used as a method of anticoagulation in plasmapheresis. Citrate provides effective anticoagulation that is completely limited to extracorporeal circulation. Patients who are at increased risk for bleeding, anticoagulation with citrate is a more appropriate method than standard heparin, while in other patients both methods are equivalent.

Citrate anticoagulation is performed by infusing citrate into the arterial line of the extracorporeal system. Citrate binds to plasma calcium and thus inhibits coagulation in the system. Calcium is added to the venous line of the system (when blood returns to the patient) to maintain a normal plasma ionized calcium concentration. Lowering the ionized calcium in the blood in the extracorporeal circulation inhibits the coagulation and activation of other systems (platelets, leukocytes, complement), which affects the biocompatibility of the artificial material and the whole procedure. Biocompatibility is extremely important, since the contact of blood with artificial material activates both the humoral and cellular systems. As part of the humoral immune system, complement is activated by the production of C3, C4 and C5, factor XIIa, there is also an increase in the production of bradykinin, kallikrein, quinine and plasmin, and some proteins are denatured (gamma globulins, fibrinogen, albumins). When the cellular immune system is activated, lymphocytosis can occur and the is also change in function of phagocytes.

All previous studies show that regional anticoagulation with citrate improves biocompatibility in hemodialysis procedures (compared to heparin anticoagulation), but no direct comparison in plasmapheresis has been observed in the literature so far.

Therefore, the investigators want to conduct a prospective randomized study comparing several parameters of heparin and citrate anticoagulation biocompatibility during plasmapheresis. The aim of the study is to demonstrate better biocompatibility in citrate anticoagulation compared to heparin.

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

  • older than 18 years
  • an indication for plasma exchange (plasmapheresis) with albumin solution as a replacement solution

排除标准

  • contraindication for systemic heparinisation
  • acute bleeding
  • known active malignancy
  • severe infection
  • anticoagulant therapy at therapeutic dose

研究组 & 干预措施

heparin anticoagulation

Active Comparator

standard heparin anticoagulation during plasmapheresis

干预措施: unfractionated heparin (Drug)

citrate anticoagulation

Experimental

sodium citrate anticoagulation during plasmapheresis

干预措施: Sodium Citrate (Drug)

结局指标

主要结局

change in serum platelet factor 4 from baseline to the end of plasmapheresis

时间窗: at the end of plasmapheresis procedure

platelet factor 4

change in serum C5a from baseline to the end of plasmapheresis

时间窗: at the end of plasmapheresis procedure

complement component C5a

change in serum myeloperoxidase from baseline to the end of plasmapheresis

时间窗: at the end of plasmapheresis procedure

myeloperoxidase

change in serum thrombin-antithrombin complex from baseline to 30 minutes

时间窗: 30 minutes after start of plasmapheresis

thrombin-antithrombin complex

change in serum thrombin-antithrombin complex from baseline to the end of plasmapheresis

时间窗: at the end of plasmapheresis procedure

thrombin-antithrombin complex

change in serum C5a from baseline to 30 minutes

时间窗: 30 minutes after start of plasmapheresis

complement component C5a

change in serum platelet factor 4 from baseline to 30 minutes

时间窗: 30 minutes after start of plasmapheresis

platelet factor 4

change in serum myeloperoxidase from baseline to 30 minutes

时间窗: 30 minutes after start of plasmapheresis

myeloperoxidase

次要结局

  • comparison of measured thrombin-antithrombin complex in patients' serum and filtered plasma(30 minutes after start of plasmapheresis)
  • comparison of measured platelet factor 4 in patients' serum and filtered plasma(30 minutes after start of plasmapheresis)
  • complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting)(during plasmapheresis)
  • comparison of measured C5a in patients' serum and filtered plasma(30 minutes after start of plasmapheresis)
  • comparison of measured myeloperoxidase in patients' serum and filtered plasma(30 minutes after start of plasmapheresis)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jakob Gubensek

Principal investigator

University Medical Centre Ljubljana

研究点 (1)

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