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Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

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University of Pittsburgh

Status

Completed

Conditions

Traumatic Injury

Study type

Observational

Funder types

Other

Identifiers

NCT01485419
NTI early sex hormone trial

Details and patient eligibility

About

Traumatic injury is a major public health problem with an immense societal cost. Despite improvements in trauma management, patients continue to suffer significant morbidity and mortality. Evidence suggests that males and females tolerate severe injury differently with a greater protection afforded to females. Determining the mechanisms responsible for these sex-based outcome differences after injury, focusing specifically on the early sex-hormone environment post-injury, may allow those at highest risk for poor outcome to be predicted and promote interventions that can improve outcomes for all injured patients. The goal of this study is to determine if the early sex hormone environment soon after injury has effects on the intensity of the immune response, resuscitation and blood transfusion requirements, and important clinical outcomes including mortality, organ failure and infection, following significant injury.

Enrollment

292 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Injury, ICU admission

Exclusion criteria

Isolated TBI, Admission beyond 6 hours

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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