Anticoagulation Clinical Trial
Official title:
Comparison of Biocompatibility of Plasmapheresis Procedures With Citrate and Heparin Anticoagulation
Verified date | November 2023 |
Source | University Medical Centre Ljubljana |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | December 30, 2022 |
Est. primary completion date | December 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - older than 18 years - an indication for plasma exchange (plasmapheresis) with albumin solution as a replacement solution Exclusion Criteria: - contraindication for systemic heparinisation - acute bleeding - known active malignancy - severe infection - anticoagulant therapy at therapeutic dose |
Country | Name | City | State |
---|---|---|---|
Slovenia | University Medical Center Ljubljana | Ljubljana |
Lead Sponsor | Collaborator |
---|---|
University Medical Centre Ljubljana |
Slovenia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in serum thrombin-antithrombin complex from baseline to 30 minutes | thrombin-antithrombin complex | 30 minutes after start of plasmapheresis | |
Primary | change in serum thrombin-antithrombin complex from baseline to the end of plasmapheresis | thrombin-antithrombin complex | at the end of plasmapheresis procedure | |
Primary | change in serum platelet factor 4 from baseline to 30 minutes | platelet factor 4 | 30 minutes after start of plasmapheresis | |
Primary | change in serum platelet factor 4 from baseline to the end of plasmapheresis | platelet factor 4 | at the end of plasmapheresis procedure | |
Primary | change in serum C5a from baseline to 30 minutes | complement component C5a | 30 minutes after start of plasmapheresis | |
Primary | change in serum C5a from baseline to the end of plasmapheresis | complement component C5a | at the end of plasmapheresis procedure | |
Primary | change in serum myeloperoxidase from baseline to 30 minutes | myeloperoxidase | 30 minutes after start of plasmapheresis | |
Primary | change in serum myeloperoxidase from baseline to the end of plasmapheresis | myeloperoxidase | at the end of plasmapheresis procedure | |
Secondary | complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting) | complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting) | during plasmapheresis | |
Secondary | comparison of measured platelet factor 4 in patients' serum and filtered plasma | A Bland-Altman agreement analysis | 30 minutes after start of plasmapheresis | |
Secondary | comparison of measured thrombin-antithrombin complex in patients' serum and filtered plasma | A Bland-Altman agreement analysis | 30 minutes after start of plasmapheresis | |
Secondary | comparison of measured C5a in patients' serum and filtered plasma | A Bland-Altman agreement analysis | 30 minutes after start of plasmapheresis | |
Secondary | comparison of measured myeloperoxidase in patients' serum and filtered plasma | A Bland-Altman agreement analysis | 30 minutes after start of plasmapheresis |
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