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Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

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ClinicalTrials.gov Identifier: NCT03801135
Recruitment Status : Recruiting
First Posted : January 11, 2019
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
Matej Zrimsek, 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.

Condition or disease Intervention/treatment Phase
Humoral Rejection Guillain-Barre Syndrome Miller Fisher Syndrome CIDP Good Pasture Syndrome Hyperviscosity Syndrome Drug: Fibrinogen concentrate Other: Fresh Frozen Plasma Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : September 24, 2019


Arm Intervention/treatment
No Intervention: Electrolyte&Albumin Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.
Experimental: Fibrinogen Treatment Group
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
Haemocomplettan will be infused after plasma exchange procedure
Other Name: Haemocomplettan

Active Comparator: FFP Treatment Group
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
Other: Fresh Frozen Plasma
Fresh frozen plasma will be part of replacement fluid




Primary Outcome Measures :
  1. Effect of plasmapheresis replacement fluid type on fibrinogen level [ Time Frame: 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 :
  1. Effect on coagulation tests after plasmapheresis - ROTEM EXTEM [ Time Frame: 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

  2. Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM [ Time Frame: 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801135


Contacts
Contact: Matej Zrimsek +38631789714 matej.zrimsek@kclj.si

Locations
Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Gorenjska, Slovenia, 1000
Contact: Matej Zrimsek    +38631789714    matej.zrimsek@kclj.si   
Sponsors and Collaborators
University Medical Centre Ljubljana

Responsible Party: Matej Zrimsek, Principal Investigator, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT03801135     History of Changes
Other Study ID Numbers: MPFhemostaza
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Matej Zrimsek, University Medical Centre Ljubljana:
Fibrinogen concentrate
Fresh frozen plasma
ROTEM
Fibrinogen
Overall coagulation potential

Additional relevant MeSH terms:
Eye Diseases
Syndrome
Guillain-Barre Syndrome
Miller Fisher Syndrome
Anti-Glomerular Basement Membrane Disease
Disease
Pathologic Processes
Polyradiculoneuropathy
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Polyneuropathies
Autoimmune Diseases
Immune System Diseases
Cerebellar Diseases
Brain Diseases
Central Nervous System Diseases
Ocular Motility Disorders
Cranial Nerve Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Citric Acid
Hemostatics