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

Acquired Platelet Function Disorder Clinical Trial

Official title:

Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery - a Prospective Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01354847
• Other study ID #: MEAECC
• Status: Completed
• Phase: N/A
• First received: May 2, 2011
• Last updated: October 25, 2013
• Start date: June 2011
• Est. completion date: October 2013

Study information

• Verified date: October 2013
• Source: Goethe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Regierungspräsidium Darmstadt, Hessen
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• duration of extracorporeal circulation > 120 min

Exclusion Criteria:

• pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acquired Platelet Function Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	Goethe - University	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Goethe University

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. doi: 10.1213/ane.0b013e3181a198ac. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in arachidonic acid induced platelet aggregation as compared to baseline (before extracorporeal circulation)	Multiple Electrode aggregometry parameters	Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU	No
Secondary	Changes in Adenosin Diphosphate (ADP) and Thrombin induced platelet aggregation as compared to baseline (before extracorporeal circulation)	Multiple electrode aggregometry analyses	Baseline (before extracorporeal circulation) and 60, 90, 120, 150 and 180 minutes after extracorporal circulation as well as ad admission to ICU	No