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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac surgery with cardiopulmary bypass |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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The population for this study will be elective cardiac surgical patients who will be undergoing elective primary cardiac surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Prakash A Patel, MD | University of Pennsylvania Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Surgery With Cardiopulmary Bypass | Patients over the age of 18 years undergoing cardiac surgery requiring CPB. Patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Surgery With Cardiopulmary Bypass | patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 49 patients undergoing cardiac surgery with CPB. | Posted | Mean | 95% Confidence Interval | mg/dL | Change in FLEV from rewarming and after cardiopulmonary bypass |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Surgery With Cardiopulmary Bypass | patients over the age of 18 years undergoing cardiac surgery requiring CPB. patients were excluded based on their need for emergency surgery, re-operative cardiac surgery, a history of coagulation disorders, and inability to sign consent. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rupa Chowdary | University of Pennsylvania Hospital | 215-615-4105 | rupa.chowdary@uphs.upenn.edu |
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| Participants |
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| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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. | 49 patients undergoing cardiac surgery with CPB. The measure is the difference of the FLEV and the Clauss assay (i.e. FLEV minus Clauss since the FLEV is consistently higher). | Posted | Mean | 95% Confidence Interval | mg/dL | Clauss vs FLEV for rewarming and post-CPB |
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| 0 |
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
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