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

NCT01485419 | Completed

• 1 other identifier: NTI early sex hormone trial
• Study Type: observational
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Injury

Keywords

Sex hormones; Testosterone; Estradiol

Outcome Measures

Primary Outcomes (1)

• Multiple Organ Failure

  7 days

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Injured patients requiring ICU admission who arrive within 6 hours of injury

You may qualify if:

• Injury, ICU admission

You may not qualify if:

• Isolated TBI, Admission beyond 6 hours

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Jason Sperry, MD, MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery and Critical Care

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: January 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)