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

Antibody-mediated Rejection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02533596
• Other study ID #: TPE-5343-2010
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: August 24, 2015
• Start date: September 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2015
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Antibody-mediated Rejection
• Autoimmune Reaction Mediated by Immune Complex

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Percentage decrease in serum levels of NT-proBNP by TPE	Elimination of NT-proBNP by TPE measured	Up to five days after enrollment	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No