Changes in Haemostasis After Therapeutic Plasmapheresis With Citrate Anticoagulation

University Medical Centre Ljubljana

Status: Unknown

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

Treatments: Other: Fresh Frozen Plasma; Drug: Fibrinogen concentrate

Study type: Interventional

Funder types: Other

Identifiers

NCT03801135

MPFhemostaza

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Electrolyte&Albumin Group

No Intervention group

Description:

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

Fibrinogen Treatment Group

Experimental group

Description:

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

Treatment:

Drug: Fibrinogen concentrate

FFP Treatment Group

Active Comparator group

Description:

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

Treatment:

Other: Fresh Frozen Plasma