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
  Purpose

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.


Condition Intervention
Acquired Platelet Function Disorder
Device: Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery - a Prospective Observational Study

Resource links provided by NLM:


Further study details as provided by Goethe University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 25
Study Start Date: June 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
cardiac surgery patients
cardiac surgery patients scheduled for elective complex cardiac surgery
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • duration of extracorporeal circulation > 120 min

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354847

Locations
Germany
Goethe - University
Frankfurt, Hessen, Germany, 60322
Sponsors and Collaborators
Goethe University
Investigators
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
  More Information

Publications:
Responsible Party: Christian F. Weber, MD, Dr. Dr. Christian Friedrich Weber, Goethe University
ClinicalTrials.gov Identifier: NCT01354847     History of Changes
Other Study ID Numbers: MEAECC
Study First Received: May 2, 2011
Last Updated: October 25, 2013
Health Authority: Germany: Regierungspräsidium Darmstadt, Hessen

Keywords provided by Goethe University:
extracorporeal circulation
platelet dysfunction
Multiplate electrode aggregometry analyses
Multiplate

ClinicalTrials.gov processed this record on September 16, 2014