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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01992757
Other study ID # 818918
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2013
Est. completion date August 2015

Study information

Verified date November 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date August 2015
Est. primary completion date August 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

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

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Change in FLEV from rewarming and after cardiopulmonary bypass
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. Clauss vs FLEV for rewarming and post-CPB
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