Thromboelastography-derived Functional Fibrinogen Levels (TEG-FF)

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

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 Overview

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

• Study Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cardiac surgery with cardiopulmary bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Prakash A Patel, MD, University of Pennsylvania Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ACTUAL): August 1, 2015
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 19, 2013
• First Posted (ESTIMATE): November 25, 2013

Study Record Updates

• Last Update Posted (ACTUAL): October 3, 2018
• Last Update Submitted That Met QC Criteria: October 2, 2018
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: cardiac surgery; functional fibrinogen assay
• Other Study ID Numbers: 818918