Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

Not Applicable

• Conditions: Humoral Rejection; Guillain-Barre Syndrome; CIDP; Good Pasture Syndrome; Miller Fisher Syndrome; Hyperviscosity Syndrome
• Interventions: Drug: Fibrinogen concentrate; Other: Fresh Frozen Plasma

• Registration Number: NCT03801135
• Lead Sponsor: University Medical Centre Ljubljana

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-03
• Study First Submitted: 2018-10-04
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-10
• Last Update Submitted: 2019-01-10
• Study First Posted: 2019-01-11
• Last Update Posted: 2019-01-11
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Every patient who will need repeated plasmapheresis treatment in UKC Ljubljana

Exclusion Criteria

• pregnancy
• coagulation disorders
• Hypertriglyceridemia-induced acute pancreatitis
• hepatic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibrinogen Treatment Group	Fibrinogen concentrate	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	Fresh Frozen Plasma	One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Gorenjska, Slovenia