Comparison of Biocompatibility of Plasmapheresis Procedures With Citrate and Heparin Anticoagulation

NCT05191290 | Completed Phase 4

• 1 other identifier: 0120-310/2017/3
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Apheresis; Anticoagulation

Outcome Measures

Primary Outcomes (8)

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

  thrombin-antithrombin complex

  30 minutes after start of plasmapheresis

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

  thrombin-antithrombin complex

  at the end of plasmapheresis procedure

• change in serum platelet factor 4 from baseline to 30 minutes

  platelet factor 4

  30 minutes after start of plasmapheresis

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

  platelet factor 4

  at the end of plasmapheresis procedure

• change in serum C5a from baseline to 30 minutes

  complement component C5a

  30 minutes after start of plasmapheresis

• change in serum C5a from baseline to the end of plasmapheresis

  complement component C5a

  at the end of plasmapheresis procedure

• change in serum myeloperoxidase from baseline to 30 minutes

  myeloperoxidase

  30 minutes after start of plasmapheresis

• change in serum myeloperoxidase from baseline to the end of plasmapheresis

  myeloperoxidase

  at the end of plasmapheresis procedure

Secondary Outcomes (5)

• complications during plasmapheresis (hypocalcemia, metabolic alkalosis, clotting)

  during plasmapheresis

• comparison of measured platelet factor 4 in patients' serum and filtered plasma

  30 minutes after start of plasmapheresis

• comparison of measured thrombin-antithrombin complex in patients' serum and filtered plasma

  30 minutes after start of plasmapheresis

• comparison of measured C5a in patients' serum and filtered plasma

  30 minutes after start of plasmapheresis

• comparison of measured myeloperoxidase in patients' serum and filtered plasma

  30 minutes after start of plasmapheresis

Study Arms (2)

heparin anticoagulation

ACTIVE COMPARATOR

standard heparin anticoagulation during plasmapheresis

Drug: unfractionated heparin

citrate anticoagulation

EXPERIMENTAL

sodium citrate anticoagulation during plasmapheresis

Drug: Sodium Citrate

Interventions

unfractionated heparin DRUG

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

heparin anticoagulation

Sodium Citrate DRUG

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

citrate anticoagulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• older than 18 years
• an indication for plasma exchange (plasmapheresis) with albumin solution as a replacement solution

You may not qualify if:

• contraindication for systemic heparinisation
• acute bleeding
• known active malignancy
• severe infection
• anticoagulant therapy at therapeutic dose

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Center Ljubljana

Ljubljana, 1210, Slovenia

Location

MeSH Terms

Interventions

Heparin; Sodium Citrate

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 13, 2022
• Study Start: January 21, 2022
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)