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Plasma exchange procedures remove procoagulant and anticoagulant factors. Every procedure increases the risk of bleeding and repeated procedures increase the risk of bleeding mostly because lower fibrinogen levels. The aim of study is to define coagulation status of patient after plasmapheresis with different laboratory tests and to investigate the possibility of fibrinogen concentrate replacement for the correction of induced coagulation disorder.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrolyte&Albumin Group | No Intervention | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. | |
| Fibrinogen Treatment Group | Experimental | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards. |
|
| FFP Treatment Group | Active Comparator | One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibrinogen concentrate | Drug | Haemocomplettan will be infused after plasma exchange procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effect of plasmapheresis replacement fluid type on fibrinogen level | Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type | Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)] |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on coagulation tests after plasmapheresis - ROTEM EXTEM | ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type | Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)] |
| Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matej Zrimsek | Contact | +38631789714 | matej.zrimsek@kclj.si |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Centre Ljubljana | Recruiting | Ljubljana | Gorenjska | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39768590 | Derived | Zrimsek M, Gubensek J, Marn Pernat A. A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with Mild to Moderate Bleeding Risk-A Comparison with Fresh Frozen Plasma and Albumin Replacement. J Clin Med. 2024 Dec 16;13(24):7662. doi: 10.3390/jcm13247662. |
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| Fresh Frozen Plasma | Other | Fresh frozen plasma will be part of replacement fluid |
|
ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type |
| Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)] |
| ID | Term |
|---|---|
| D020275 | Guillain-Barre Syndrome |
| D019846 | Miller Fisher Syndrome |
| D020277 | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating |
| D019867 | Anti-Glomerular Basement Membrane Disease |
| ID | Term |
|---|---|
| D011129 | Polyradiculoneuropathy |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002526 | Cerebellar Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D005128 | Eye Diseases |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D005340 | Fibrinogen |
| ID | Term |
|---|---|
| D000209 | Acute-Phase Proteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001779 | Blood Coagulation Factors |
| D011498 | Protein Precursors |
| D001685 | Biological Factors |
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