Thromboelastography-derived Functional Fibrinogen Levels

NCT01992757 | Completed Results

• 1 other identifier: 818918
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

functional fibrinogen assay; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Difference in Clauss Assay and FLEV

  Clauss vs FLEV for rewarming and post-CPB

Study Arms (1)

Cardiac surgery with cardiopulmary bypass

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Elective cardiac surgery patients who are undergoing primary cardiac surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Results Point of Contact

• Title: Rupa Chowdary
• Organization: University of Pennsylvania Hospital

rupa.chowdary@uphs.upenn.edu

215-615-4105

Study Officials

• Prakash A Patel, MD

  University of Pennsylvania Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 3, 2018
• Results First Posted: October 3, 2018

Record last verified: 2017-11

Locations

US (1)