Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

Guillain-Barre Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03801135
• Other study ID #: MPFhemostaza
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2018
• Est. completion date: September 24, 2019

Study information

• Verified date: January 2019
• Source: University Medical Centre Ljubljana
• Contact: Matej Zrimsek
• Phone: +38631789714
• Email: matej.zrimsek[@]kclj.si
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 24, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy

• coagulation disorders

• Hypertriglyceridemia-induced acute pancreatitis

• hepatic disorders

Related Conditions & MeSH terms

• Anti-Glomerular Basement Membrane Disease
• CIDP
• Good Pasture Syndrome
• Guillain-Barre Syndrome
• Humoral Rejection
• Hyperviscosity Syndrome
• Miller Fisher Syndrome
• Syndrome

Intervention

Drug:
• Fibrinogen concentrate
Haemocomplettan will be infused after plasma exchange procedure

Other:
• Fresh Frozen Plasma
Fresh frozen plasma will be part of replacement fluid

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana	Gorenjska

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)]
Secondary	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)]