Coagulation Status of Cardiac Surgery Patient, Focus of Study, Reducing Excess Blood Transfusion
Conditions
Keywords
functional fibrinogen assay, cardiac surgery
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
Interventions
None listed
Sponsors
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 49 |
| Total | 49 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | 2 patients excluded due to FFP given. | 2 |
Baseline characteristics
| Characteristic | Cardiac Surgery With Cardiopulmary Bypass | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 23 Participants | — |
| Age, Categorical Between 18 and 65 years | 26 Participants | — |
| Age, Continuous | 63.1 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 49 participants | — |
| Sex: Female, Male Female | 20 Participants | — |
| Sex: Female, Male Male | 29 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 0 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
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.
Time frame: Change in FLEV from rewarming and after cardiopulmonary bypass
Population: 49 patients undergoing cardiac surgery with CPB.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FLEV Difference During Rewarming & Post-cardiopulmonary Bypass | Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) | -1.1 mg/dL |
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.
Time frame: Clauss vs FLEV for rewarming and post-CPB
Population: 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).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| FLEV Difference During Rewarming & Post-cardiopulmonary Bypass | Difference in Clauss Assay and FLEV | Mean Clauss vs FLEV difference at rewarming | 120.6 mg/dL |
| FLEV Difference During Rewarming & Post-cardiopulmonary Bypass | Difference in Clauss Assay and FLEV | Mean Clauss vs FLEV difference post-CPB | 119.5 mg/dL |