A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Effect of plasmapheresis replacement fluid type on fibrinogen level
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana
Exclusion Criteria
- •pregnancy
- •coagulation disorders
- •Hypertriglyceridemia-induced acute pancreatitis
- •hepatic disorders
Arms & Interventions
Fibrinogen Treatment Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.
Intervention: Fibrinogen concentrate (Drug)
FFP Treatment Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
Intervention: Fresh Frozen Plasma (Other)
Outcomes
Primary Outcomes
Effect of plasmapheresis replacement fluid type on fibrinogen level
Time Frame: Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
Secondary Outcomes
- Effect on coagulation tests after plasmapheresis - ROTEM EXTEM(Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)])
- Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM(Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)])
Investigators
Matej Zrimsek
Principal Investigator
University Medical Centre Ljubljana