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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01485419
First Posted: December 5, 2011
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh
  Purpose
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.

Condition
Traumatic Injury

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of the Early Sex Hormone Milieu Post Injury and Relationship With Resuscitation Requirements and Coagulopathy

Resource links provided by NLM:


Further study details as provided by Jason Sperry, University of Pittsburgh:

Primary Outcome Measures:
  • Multiple Organ Failure [ Time Frame: 7 days ]

Enrollment: 292
Study Start Date: January 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Injured patients requiring ICU admission who arrive within 6 hours of injury
Criteria

Inclusion Criteria:

Injury, ICU admission

Exclusion Criteria:

Isolated TBI, Admission beyond 6 hours

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01485419


Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Jason Sperry, MD, MPH University of Pittsburgh
  More Information

Responsible Party: Jason Sperry, Assistant Professor of Surgery and Critical Care, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01485419     History of Changes
Other Study ID Numbers: NTI early sex hormone trial
First Submitted: December 1, 2011
First Posted: December 5, 2011
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by Jason Sperry, University of Pittsburgh:
Sex hormones
Testosterone
Estradiol

Additional relevant MeSH terms:
Wounds and Injuries
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs