Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian F. Weber, MD, Goethe University
ClinicalTrials.gov Identifier:
NCT01354847
First received: May 2, 2011
Last updated: October 25, 2013
Last verified: October 2013

May 2, 2011
October 25, 2013
June 2011
October 2013   (final data collection date for primary outcome measure)
Changes in arachidonic acid induced platelet aggregation as compared to baseline (before extracorporeal circulation) [ Time Frame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU ] [ Designated as safety issue: No ]
Multiple Electrode aggregometry parameters
Changes in arachidonic acid induced platelet aggregation as compared to baseline (before extracorporeal circulation) [ Time Frame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU ] [ Designated as safety issue: No ]
MEA parameter
Complete list of historical versions of study NCT01354847 on ClinicalTrials.gov Archive Site
Changes in Adenosin Diphosphate (ADP) and Thrombin induced platelet aggregation as compared to baseline (before extracorporeal circulation) [ Time Frame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU ] [ Designated as safety issue: No ]
Multiple electrode aggregometry analyses
Changes in ADP and Thrombin induced platelet aggregation as compared to baseline (before extracorporeal circulation) [ Time Frame: Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU ] [ Designated as safety issue: No ]
MEA analyses
Not Provided
Not Provided
 
Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery
Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery - a Prospective Observational Study

This study is planned to investigate the relationship between duration of extracorporeal circulation and the extent of (acquired) platelet dysfunctions in patients undergoing cardiac surgery.

Patients undergoing complex cardiac surgery are planned to be included. At several intra- and postoperative measuring point, blood is drawn for multiple electrode aggregometry to investigate ex-vivo platelet aggregation as a surrogate for platelet function.

Transfusion rate of allogenic blood products as well as postoperative blood loss is planned to be recorded.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Cardiac surgery patients undergoing complex cardiac surgery (double valve, aortic surgery, combined - or redo procedures)

Acquired Platelet Function Disorder
Device: Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)
ex vivo platelet aggregation at several intraoperative and postoperative measuring points.
cardiac surgery patients
cardiac surgery patients scheduled for elective complex cardiac surgery
Intervention: Device: Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)
Velik-Salchner C, Maier S, Innerhofer P, Kolbitsch C, Streif W, Mittermayr M, Praxmarer M, Fries D. An assessment of cardiopulmonary bypass-induced changes in platelet function using whole blood and classical light transmission aggregometry: the results of a pilot study. Anesth Analg. 2009 Jun;108(6):1747-54.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
October 2013
October 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • duration of extracorporeal circulation > 120 min

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01354847
MEAECC
No
Christian F. Weber, MD, Goethe University
Goethe University
Not Provided
Principal Investigator: Christian F Weber, M.D. Goethe University Frankfurt, Theodor Stern Kai 7, 60590 Frankfurt, Germany
Study Chair: Christian Reyher, M.D. Goethe University Frankfurt, Clinic for Anesthesiology, Theodor Stern Kai 7, 60590 Frankfurt, Germany
Goethe University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP