N/A
N=51
Thromboelastography-derived Functional Fibrinogen Levels
Focus of Study · Coagulation Status of Cardiac Surgery Patient · Reducing Excess Blood Transfusion
Bottom Line
View on ClinicalTrials.gov: NCT01992757 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Oct 2018
Primary outcome: Primary: Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) — -1.1 mg/dL
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Thromboelastography-derived Functional Fibrinogen Level (FLEV) |
-1.1 | — |
| SECONDARY Difference in Clauss Assay and FLEV |
120.6; 119.5 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01992757). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.