Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery
This study is currently recruiting participants.
Verified March 2013 by Goethe University
Sponsor:
Goethe University
Information provided by (Responsible Party):
Christian F. Weber, Goethe University
ClinicalTrials.gov Identifier:
NCT01354847
First received: May 2, 2011
Last updated: March 19, 2013
Last verified: March 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | May 2, 2011 | ||||||||
| Last Updated Date | March 19, 2013 | ||||||||
| Start Date ICMJE | June 2011 | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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 |
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| Change History | Complete list of historical versions of study NCT01354847 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 |
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| Original Secondary Outcome Measures ICMJE |
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 |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery | ||||||||
| Official Title ICMJE | Influence of Extracorporeal Circulation on Platelet Function of Patients Undergoing Cardiac Surgery - a Prospective Observational Study | ||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Cardiac surgery patients undergoing complex cardiac surgery (double valve, aortic surgery, combined - or redo procedures) |
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| Condition ICMJE | Acquired Platelet Function Disorder | ||||||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | 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) |
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| Publications * | 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. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 30 | ||||||||
| Completion Date | Not Provided | ||||||||
| Estimated Primary Completion Date | October 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01354847 | ||||||||
| Other Study ID Numbers ICMJE | MEAECC | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Christian F. Weber, Goethe University | ||||||||
| Study Sponsor ICMJE | Goethe University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Goethe University | ||||||||
| Verification Date | March 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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