Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome, CIDP, Good Pasture Syndrome, Hyperviscosity Syndrome
Conditions
Keywords
Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential
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.
Interventions
Haemocomplettan will be infused after plasma exchange procedure
OTHERFresh Frozen Plasma
Fresh frozen plasma will be part of replacement fluid
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of plasmapheresis replacement fluid type on fibrinogen level | 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
| Measure | Time frame | Description |
|---|---|---|
| Effect on coagulation tests after plasmapheresis - ROTEM EXTEM | Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)] | ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type |
| Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM | Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)] | ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type |
Countries
Slovenia
Contacts
Primary ContactMatej Zrimsek
Outcome results
None listed