Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

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.

Official Title
-----------------
A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement

Conditions
-----------------
Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome, CIDP, Good Pasture Syndrome, Hyperviscosity Syndrome

Intervention / Treatment
-----------------
* Drug: Fibrinogen concentrate
* Other: Fresh Frozen Plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana Exclusion Criteria: pregnancy coagulation disorders Hypertriglyceridemia-induced acute pancreatitis hepatic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Electrolyte&Albumin Group<br>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. | |
| Experimental: Fibrinogen Treatment Group<br>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards. | Drug: Fibrinogen concentrate<br>* Haemocomplettan will be infused after plasma exchange procedure<br>* Other names: Haemocomplettan;|
| Active Comparator: FFP Treatment Group<br>One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma. | Other: Fresh Frozen Plasma<br>* Fresh frozen plasma will be part of replacement fluid<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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)] | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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)] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential