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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jason Sperry, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01485419
First received: December 1, 2011
Last updated: February 18, 2014
Last verified: February 2014
  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 University of Pittsburgh:

Primary Outcome Measures:
  • Multiple Organ Failure [ Time Frame: 7 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 1, 2011
Last Updated: February 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Sex hormones
Testosterone
Estradiol

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

ClinicalTrials.gov processed this record on October 21, 2014