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Thromboelastography-derived Functional Fibrinogen Levels (TEG-FF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992757
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : October 3, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
This study hopes to determine if thromboelastography-derived functional fibrinogen (TEG-FF or FLEV) levels obtained during the rewarming phase of cardiopulmonary bypass can provide information on coagulation status sooner, allowing for anticipation of post-bypass bleeding and transfusion requirements

Condition or disease
Focus of Study Coagulation Status of Cardiac Surgery Patient Reducing Excess Blood Transfusion

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Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Group/Cohort
Cardiac surgery with cardiopulmary bypass



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.
Criteria

Inclusion Criteria:

  • Elective cardiac surgery patients who are undergoing primary cardiac surgery

Exclusion Criteria:

  • Emergency surgery
  • Re-operative cardiac surgery
  • History of hypercoagulable state as defined in medical record
  • Anticoagulated status at time of surgery
  • Plasma requirement prior to discontinuation of bypass (alters fibrinogen level)

Information from the National Library of Medicine

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


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Prakash A Patel, MD University of Pennsylvania Hospital
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01992757    
Other Study ID Numbers: 818918
First Posted: November 25, 2013    Key Record Dates
Results First Posted: October 3, 2018
Last Update Posted: October 3, 2018
Last Verified: November 2017
Keywords provided by University of Pennsylvania:
functional fibrinogen assay
cardiac surgery