Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange

Completed

• Conditions: Antibody-mediated Rejection; Autoimmune Reaction Mediated by Immune Complex

• Registration Number: NCT02533596
• Lead Sponsor: Hannover Medical School

Brief Summary

Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.

Detailed Description

We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.

Study Timeline

• Study Start: 2010-09
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Status Verified: 2015-02
• Study First Submitted: 2015-02-27
• Study First Submitted QC: 2015-08-24
• Last Update Submitted: 2015-08-24
• Study First Posted: 2015-08-27
• Last Update Posted: 2015-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• indication for TPE
• age between 18 and 80 years
• written informed consent

Exclusion Criteria

• need for fresh-frozen plasma as replacement fluid
• participation in another study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage decrease in serum levels of Troponin T by TPE	Up to five days after enrollment	Elimination of cardiac biomarkers Troponin T by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of procalcitonin by TPE	Up to five days after enrollment	Elimination of procalcitonin by TPE measured by the decrease in serum
Percentage decrease in serum levels of C-reactive protein by TPE	Up to five days after enrollment	Elimination of C-reactive protein by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of NT-proBNP by TPE	Up to five days after enrollment	Elimination of NT-proBNP by TPE measured

Secondary Outcome Measures

Name	Time	Method
Total eliminated amount of NT-proBNP by TPE	Up to five days after enrollment	Elimination of NT-proBNP by TPE measured by the total eliminated amount in the exchanged plasma.
Total eliminated amount of procalcitonin by TPE	Up to five days after enrollment	Elimination of procalcitonin by TPE measured by the total eliminated amount in the exchanged plasma.
Total eliminated amount of C-reactive protein by TPE	Up to five days after enrollment	Elimination of C-reactive protein by TPE measured by the total eliminated amount in the exchanged plasma.
Percentage decrease in serum levels of adipokines by TPE	Up to five days after enrollment	Elimination of adipokines by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Total eliminated amount of Troponin T by TPE	Up to five days after enrollment	Elimination of Troponin T by TPE measured by the total eliminated amount in the exchanged plasma.
Total eliminated amount of adipokines by TPE	Up to five days after enrollment	Elimination of adipokines by TPE measured by the total eliminated amount in the exchanged plasma.

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany