Clinical trial

Comparison of Biocompatibility of Plasmapheresis Procedures With Citrate and Heparin Anticoagulation

NCT05191290

Name

0120-310/2017/3

Description

Membrane plasmapheresis is one of the methods for treating immune diseases. Plasmapheresis removes autoantibodies and immune complexes, paraproteins, lipoproteins and reduces the concentration of cytokines. In membrane plasmapheresis, plasma is separated from blood cells by a highly permeable membrane. The filtered plasma is then discarded and replaced with replacement fluid. During the procedure, there is an activation of the coagulation system, because of the extracorporeal blood circulation. The anticoagulation during the procedure is therefore necessary.

Trial arms

Trial start

2022-01-21

Estimated PCD

2022-12-30

Trial end

2022-12-30

Status

Completed

Phase

Early phase I

Treatment

unfractionated heparin

standard heparin at 2500 IU i.v. bolus and then 2000 IU/h continuously i.v. for anticoagulation during plasmapheresis

Arms:

heparin anticoagulation

Sodium Citrate

8% sodium citrate at approx. 27 mmol/h i.v. for anticoagulation during plasmapheresis

Arms:

citrate anticoagulation

Size

Primary endpoint

change in serum thrombin-antithrombin complex from baseline to 30 minutes

30 minutes after start of plasmapheresis

change in serum thrombin-antithrombin complex from baseline to the end of plasmapheresis

at the end of plasmapheresis procedure

change in serum platelet factor 4 from baseline to 30 minutes

30 minutes after start of plasmapheresis

change in serum platelet factor 4 from baseline to the end of plasmapheresis

at the end of plasmapheresis procedure

change in serum C5a from baseline to 30 minutes

30 minutes after start of plasmapheresis

change in serum C5a from baseline to the end of plasmapheresis

at the end of plasmapheresis procedure

change in serum myeloperoxidase from baseline to 30 minutes

30 minutes after start of plasmapheresis

change in serum myeloperoxidase from baseline to the end of plasmapheresis

at the end of plasmapheresis procedure

Eligibility criteria

Inclusion Criteria: * older than 18 years * an indication for plasma exchange (plasmapheresis) with albumin solution as a replacement solution Exclusion Criteria: * contraindication for systemic heparinisation * acute bleeding * known active malignancy * severe infection * anticoagulant therapy at therapeutic dose

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ACTUAL'}}

Updated at

2023-11-29

1 organization

1 product

1 drug

2 indications

Organization

University Medical Centre Ljubljana

Drug

unfractionated heparin

Indication

Apheresis

Indication

Anticoagulant therapy

Product

Sodium Citrate