NCT03801135

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 4, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2019

Completed
Last Updated

January 11, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

October 4, 2018

Last Update Submit

January 10, 2019

Conditions

Humoral RejectionGuillain-Barre SyndromeMiller Fisher SyndromeCIDPGood Pasture SyndromeHyperviscosity Syndrome

Keywords

Fibrinogen concentrateFresh frozen plasmaROTEMFibrinogenOverall coagulation potential

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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)]

Study Arms (3)

Electrolyte&Albumin Group

NO INTERVENTION

One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.

Fibrinogen Treatment Group

EXPERIMENTAL

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

FFP Treatment Group

ACTIVE COMPARATOR

One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.

Other: Fresh Frozen Plasma

Interventions

Fibrinogen concentrateDRUG

Haemocomplettan will be infused after plasma exchange procedure

Also known as: Haemocomplettan
Fibrinogen Treatment Group
Fresh Frozen PlasmaOTHER

Fresh frozen plasma will be part of replacement fluid

FFP Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Gorenjska, 1000, Slovenia

RECRUITING

Related Publications (1)

  • Zrimsek M, Gubensek J, Marn Pernat A. A Pilot Study on the Replacement of Fibrinogen with Fibrinogen Concentrates During Therapeutic Plasma Exchange with Mild to Moderate Bleeding Risk-A Comparison with Fresh Frozen Plasma and Albumin Replacement. J Clin Med. 2024 Dec 16;13(24):7662. doi: 10.3390/jcm13247662.

    PMID: 39768590DERIVED

MeSH Terms

Conditions

Guillain-Barre SyndromeMiller Fisher SyndromePolyradiculoneuropathy, Chronic Inflammatory DemyelinatingAnti-Glomerular Basement Membrane Disease

Interventions

Fibrinogen

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebellar DiseasesBrain DiseasesCentral Nervous System DiseasesOcular Motility DisordersCranial Nerve DiseasesEye DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological Factors

Central Study Contacts

Matej Zrimsek

CONTACT

+38631789714matej.zrimsek@kclj.si

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 4, 2018

First Posted

January 11, 2019

Study Start

October 3, 2018

Primary Completion

September 1, 2019

Study Completion

September 24, 2019

Last Updated

January 11, 2019

Record last verified: 2019-01

Locations

SL(1)