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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

Tracking Information
First Submitted Date  ICMJE October 4, 2018
First Posted Date  ICMJE January 11, 2019
Last Update Posted Date January 11, 2019
Actual Study Start Date  ICMJE October 3, 2018
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
Official Title  ICMJE A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Humoral Rejection
  • Guillain-Barre Syndrome
  • Miller Fisher Syndrome
  • CIDP
  • Good Pasture Syndrome
  • Hyperviscosity Syndrome
Intervention  ICMJE
  • Drug: Fibrinogen concentrate
    Haemocomplettan will be infused after plasma exchange procedure
    Other Name: Haemocomplettan
  • Other: Fresh Frozen Plasma
    Fresh frozen plasma will be part of replacement fluid
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fibrinogen concentrate
  • Active Comparator: FFP Treatment Group
    One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
    Intervention: Other: Fresh Frozen Plasma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 10, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 24, 2019
Estimated Primary Completion Date September 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • pregnancy
  • coagulation disorders
  • Hypertriglyceridemia-induced acute pancreatitis
  • hepatic disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Matej Zrimsek +38631789714 matej.zrimsek@kclj.si
Listed Location Countries  ICMJE Slovenia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03801135
Other Study ID Numbers  ICMJE MPFhemostaza
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Matej Zrimsek, University Medical Centre Ljubljana
Study Sponsor  ICMJE University Medical Centre Ljubljana
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Medical Centre Ljubljana
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP