Thromboelastography-derived Functional Fibrinogen Levels (TEG-FF)
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|ClinicalTrials.gov Identifier: NCT01992757|
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
|Condition or disease|
|Focus of Study Coagulation Status of Cardiac Surgery Patient Reducing Excess Blood Transfusion|
|Study Type :||Observational|
|Actual Enrollment :||51 participants|
|Official Title:||Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
|Cardiac surgery with cardiopulmary bypass|
- Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) [ Time Frame: Change in FLEV from rewarming and after cardiopulmonary bypass ]FLEV values obtained during rewarming while on cardiopulmonary bypass (CPB) were compared to FLEV values obtained immediately after CPB and protamine administration. For all patients included, the mean values for rewarming FLEV and mean values for post-CPB FLEV were obtained. If the mean difference for the two timepoints was not statistically different by t-test, then the primary outcome would demonstrate the value of obtaining a rewarming FLEV sample.
- Difference in Clauss Assay and FLEV [ Time Frame: Clauss vs FLEV for rewarming and post-CPB ]This secondary outcome aimed to determine if standard laboratory assays for fibrinogen (Clauss) provided values similar to TEG-based functional fibrinogen (FLEV). The difference between the means at various timepoints is calculated in mg/dL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992757
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Prakash A Patel, MD||University of Pennsylvania Hospital|