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Completed

NCT Number: NCT02533596

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.

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Key information

Conditions

Antibody-mediated Rejection Autoimmune Reaction Mediated by Immune Complex

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hannover Medical School

Hanover, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Percentage decrease in serum levels of C-reactive protein by TPE

    Time frame: 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.

  2. Percentage decrease in serum levels of Troponin T by TPE

    Time frame: 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.

  3. Percentage decrease in serum levels of procalcitonin by TPE

    Time frame: Up to five days after enrollment

    Elimination of procalcitonin by TPE measured by the decrease in serum

  4. Percentage decrease in serum levels of NT-proBNP by TPE

    Time frame: Up to five days after enrollment

    Elimination of NT-proBNP by TPE measured

Secondary outcomes

  1. Percentage decrease in serum levels of adipokines by TPE

    Time frame: Up to five days after enrollment

    Elimination of adipokines by TPE measured by the decrease in serum levels after two consecutive TPE sessions.

  2. Total eliminated amount of Troponin T by TPE

    Time frame: Up to five days after enrollment

    Elimination of Troponin T by TPE measured by the total eliminated amount in the exchanged plasma.

  3. Total eliminated amount of NT-proBNP by TPE

    Time frame: Up to five days after enrollment

    Elimination of NT-proBNP by TPE measured by the total eliminated amount in the exchanged plasma.

  4. Total eliminated amount of procalcitonin by TPE

    Time frame: Up to five days after enrollment

    Elimination of procalcitonin by TPE measured by the total eliminated amount in the exchanged plasma.

  5. Total eliminated amount of C-reactive protein by TPE

    Time frame: Up to five days after enrollment

    Elimination of C-reactive protein by TPE measured by the total eliminated amount in the exchanged plasma.

  6. Total eliminated amount of adipokines by TPE

    Time frame: Up to five days after enrollment

    Elimination of adipokines by TPE measured by the total eliminated amount in the exchanged plasma.

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Aug 27, 2015
Registry last updated
Aug 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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