Thromboelastography-derived Functional Fibrinogen Levels

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: TEG-FF

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2015
First posted: Nov 25, 2013
Registry last updated: Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed