Thromboelastography-derived Functional Fibrinogen Levels

N/ACompletedNCT01992757

University of Pennsylvania51 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: Change in FLEV from rewarming and after cardiopulmonary bypass

Secondary Outcomes

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.

Time frame: Clauss vs FLEV for rewarming and post-CPB

Data from ClinicalTrials.gov

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