Thromboelastography-derived Functional Fibrinogen Levels

Completed

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

• Registration Number: NCT01992757
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-11
• Results First Submitted: 2017-11-06
• Results First Submitted QC: 2018-10-02
• Last Update Submitted: 2018-10-02
• Results First Posted: 2018-10-03
• Last Update Posted: 2018-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Elective cardiac surgery patients who are undergoing primary cardiac surgery

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV)	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

Name	Time	Method
Difference in Clauss Assay and FLEV	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.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States