Thromboelastography-derived Functional Fibrinogen Levels

NCT ID: NCT01992757

Last Updated: 2018-10-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-08-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cardiac surgery with cardiopulmary bypass

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prakash A Patel, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania Hospital

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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818918

Identifier Type: -

Identifier Source: org_study_id

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