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

NCT ID: NCT01485419

Last Updated: 2017-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

292 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Traumatic Injury

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

Injury, ICU admission

Exclusion Criteria

Isolated TBI, Admission beyond 6 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Jason Sperry

Assistant Professor of Surgery and Critical Care

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Sperry, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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NTI early sex hormone trial

Identifier Type: -

Identifier Source: org_study_id

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