Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

January 10, 2019 updated by: Matej Zrimsek, University Medical Centre Ljubljana

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovenia
    • Gorenjska
      • Ljubljana, Gorenjska, Slovenia, 1000
        • Recruiting
        • University Medical Centre Ljubljana
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
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
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Centre Ljubljana

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2018

Primary Completion (Anticipated)

September 1, 2019

Study Completion (Anticipated)

September 24, 2019

Study Registration Dates

First Submitted

October 4, 2018

First Submitted That Met QC Criteria

January 10, 2019

First Posted (Actual)

January 11, 2019

Study Record Updates

Last Update Posted (Actual)

January 11, 2019

Last Update Submitted That Met QC Criteria

January 10, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPFhemostaza

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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