A Phase 4 interventional study of unfractionated heparin and Sodium Citrate in Apheresis and Anticoagulation, sponsored by University Medical Centre Ljubljana. Completed at 1 site in Slovenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-29.
Sponsored by University Medical Centre Ljubljana · Phase 4, Interventional, and Treatment
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.
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.
University Medical Centre Ljubljana is the lead sponsor of 284 studies on the registry; 71 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
standard heparin anticoagulation during plasmapheresis
Drug: unfractionated heparin
sodium citrate anticoagulation during plasmapheresis
Drug: Sodium Citrate
standard heparin at 2500 IU i.v. bolus and then 2000 IU/h continuously i.v. for anticoagulation during plasmapheresis
8% sodium citrate at approx. 27 mmol/h i.v. for anticoagulation during plasmapheresis
change in serum thrombin-antithrombin complex from baseline to 30 minutes
thrombin-antithrombin complex
Time frame: 30 minutes after start of plasmapheresis
change in serum thrombin-antithrombin complex from baseline to the end of plasmapheresis
thrombin-antithrombin complex
Time frame: at the end of plasmapheresis procedure
change in serum platelet factor 4 from baseline to 30 minutes
platelet factor 4
Time frame: 30 minutes after start of plasmapheresis
change in serum platelet factor 4 from baseline to the end of plasmapheresis
platelet factor 4
Time frame: at the end of plasmapheresis procedure
change in serum C5a from baseline to 30 minutes
complement component C5a
Time frame: 30 minutes after start of plasmapheresis
change in serum C5a from baseline to the end of plasmapheresis
complement component C5a
Time frame: at the end of plasmapheresis procedure
change in serum myeloperoxidase from baseline to 30 minutes
myeloperoxidase
Time frame: 30 minutes after start of plasmapheresis
change in serum myeloperoxidase from baseline to the end of plasmapheresis
myeloperoxidase
Time frame: at the end of plasmapheresis procedure
complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting)
complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting)
Time frame: during plasmapheresis
comparison of measured platelet factor 4 in patients' serum and filtered plasma
A Bland-Altman agreement analysis
Time frame: 30 minutes after start of plasmapheresis
comparison of measured thrombin-antithrombin complex in patients' serum and filtered plasma
A Bland-Altman agreement analysis
Time frame: 30 minutes after start of plasmapheresis
comparison of measured C5a in patients' serum and filtered plasma
A Bland-Altman agreement analysis
Time frame: 30 minutes after start of plasmapheresis
comparison of measured myeloperoxidase in patients' serum and filtered plasma
A Bland-Altman agreement analysis
Time frame: 30 minutes after start of plasmapheresis
Plan to share: No
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University Medical Centre Ljubljana