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Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

Primary Purpose

Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Fibrinogen concentrate
Fresh Frozen Plasma
Sponsored by
University Medical Centre Ljubljana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Humoral Rejection focused on measuring Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • University Medical Centre LjubljanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Electrolyte&Albumin Group

Fibrinogen Treatment Group

FFP Treatment Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Effect of plasmapheresis replacement fluid type on fibrinogen level
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type

Secondary Outcome Measures

Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type

Full Information

First Posted
October 4, 2018
Last Updated
January 10, 2019
Sponsor
University Medical Centre Ljubljana
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1. Study Identification

Unique Protocol Identification Number
NCT03801135
Brief Title
Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation
Official Title
A Prospective Interventional Study to Investigate Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation With or Without Coagulation Factors Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 3, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 24, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Centre Ljubljana

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humoral Rejection, Guillain-Barre Syndrome, Miller Fisher Syndrome, CIDP, Good Pasture Syndrome, Hyperviscosity Syndrome
Keywords
Fibrinogen concentrate, Fresh frozen plasma, ROTEM, Fibrinogen, Overall coagulation potential

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electrolyte&Albumin Group
Arm Type
No Intervention
Arm Description
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin.
Arm Title
Fibrinogen Treatment Group
Arm Type
Experimental
Arm Description
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution and albumin. Fibrinogen concentrate will be infused afterwards.
Arm Title
FFP Treatment Group
Arm Type
Active Comparator
Arm Description
One calculated plasma volume will be replaced with a mixture of electrolyte replacement solution, albumin and fresh frozen plasma.
Intervention Type
Drug
Intervention Name(s)
Fibrinogen concentrate
Other Intervention Name(s)
Haemocomplettan
Intervention Description
Haemocomplettan will be infused after plasma exchange procedure
Intervention Type
Other
Intervention Name(s)
Fresh Frozen Plasma
Intervention Description
Fresh frozen plasma will be part of replacement fluid
Primary Outcome Measure Information:
Title
Effect of plasmapheresis replacement fluid type on fibrinogen level
Description
Change of fibrinogen level after plasmapheresis treatment depending on replacement fluid type
Time Frame
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Secondary Outcome Measure Information:
Title
Effect on coagulation tests after plasmapheresis - ROTEM EXTEM
Description
ROTEM (EXTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
Time Frame
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]
Title
Effect on coagulation tests after plasmapheresis - ROTEM FIBTEM
Description
ROTEM (FIBTEM MCF) change after plasmapheresis treatment depending on replacement fluid type
Time Frame
Right after every plasmapheresis session, during the whole plasmapheresis treatment (usually about 2 weeks)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matej Zrimsek
Phone
+38631789714
Email
matej.zrimsek@kclj.si
Facility Information:
Facility Name
University Medical Centre Ljubljana
City
Ljubljana
State/Province
Gorenjska
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matej Zrimsek
Phone
+38631789714
Email
matej.zrimsek@kclj.si

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

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