Thromboelastography-derived Functional Fibrinogen Levels

Focus of Study Clinical Trial

— TEG-FF  

Official title:

Comparison of Thromboelastography-derived Functional Fibrinogen Levels During and After Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01992757
• Other study ID #: 818918
• Status: Completed
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: November 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Coagulation Status of Cardiac Surgery Patient
• Focus of Study
• Reducing Excess Blood Transfusion

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)	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.	Change in FLEV from rewarming and after cardiopulmonary bypass
Secondary	Difference in Clauss Assay and FLEV	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.	Clauss vs FLEV for rewarming and post-CPB