Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

NCT ID: NCT03801135

Last Updated: 2019-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-03

Study Completion Date

2019-09-24

Brief Summary

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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

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Conditions

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Humoral Rejection Guillain-Barre Syndrome Miller Fisher Syndrome CIDP Good Pasture Syndrome Hyperviscosity Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Electrolyte&Albumin Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Fibrinogen concentrate

Intervention Type DRUG

Haemocomplettan will be infused after plasma exchange procedure

FFP Treatment Group

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

Group Type ACTIVE_COMPARATOR

Fresh Frozen Plasma

Intervention Type OTHER

Fresh frozen plasma will be part of replacement fluid

Interventions

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Fibrinogen concentrate

Haemocomplettan will be infused after plasma exchange procedure

Intervention Type DRUG

Fresh Frozen Plasma

Fresh frozen plasma will be part of replacement fluid

Intervention Type OTHER

Other Intervention Names

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Haemocomplettan

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnancy
* coagulation disorders
* Hypertriglyceridemia-induced acute pancreatitis
* hepatic disorders
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Matej Zrimsek

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Medical Centre Ljubljana

Ljubljana, Gorenjska, Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Matej Zrimsek

Role: CONTACT

+38631789714

Facility Contacts

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Matej Zrimsek

Role: primary

+38631789714

References

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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.

Reference Type DERIVED
PMID: 39768590 (View on PubMed)

Other Identifiers

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MPFhemostaza

Identifier Type: -

Identifier Source: org_study_id

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