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

Completed

• Conditions: Traumatic Injury

• Registration Number: NCT01485419
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-02
• Study First Posted: 2011-12-05
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

Injury, ICU admission

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Exclusion Criteria

Isolated TBI, Admission beyond 6 hours

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multiple Organ Failure	7 days

Trial Locations

Locations (1)

UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States