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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany
    • Hannover Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Tertiary hospital patients after kidney transplantation with humoral rejection and patients with other antibody mediated diseases.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Principal Investigator: Jan T Kielstein, Prof., Hannover Medical School

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): March 1, 2011

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (ESTIMATE): August 27, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 24, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: TPE-5343-2010