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Detection of Immune Changes as a Result of Surgical Trauma in Human Subject

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University
ClinicalTrials.gov Identifier:
NCT01578798
First received: March 23, 2012
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

Surgical trauma triggers a massive inflammatory response. Over time, both the innate and adaptive branches of the immune system are affected by surgical trauma. The purpose of this study to characterize the cellular and molecular mechanisms immune response to surgical trauma. Additionally, detailed information about patients' recovery profile will be recorded over a period of 6 weeks, with the eventual goal of linking immune responses to recovery profiles.


Condition
Surgical Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Immune Changes as a Result of Surgical Trauma in Human Subject

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Mass cytometry of immune signaling events [ Time Frame: Blood samples for mass cytometry will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op. ] [ Designated as safety issue: No ]
    The primary molecular outcome is the fold change in phosphorylation of signaling proteins.


Secondary Outcome Measures:
  • Surgical Recovery Scale (SRS) [ Time Frame: Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks. ] [ Designated as safety issue: No ]
    The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) [ Time Frame: Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks. ] [ Designated as safety issue: No ]
    Western Ontario and McMaster Universities Arthritis Index is a validated questionnaires yielding a numerical score and assessing functional status and pain in patients suffering from osteoarthritis of the hip.

  • Plasma cytokines [ Time Frame: Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op. ] [ Designated as safety issue: No ]
    The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.


Biospecimen Retention:   Samples With DNA

Whole blood


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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

Patients undergoing primary hip replacement.

Criteria

Inclusion Criteria:

  • 18 - 90
  • Planning to undergo hip surgery
  • Fluent in English
  • Willing and able to sign informed consent and HIPAA authorization

Exclusion Criteria:

  • Any systemic disease that might compromise the immune system
  • Diagnosis of cancer within the last 5 years
  • Psychiatric, immunological, and neurological conditions that would interfere with the collection and interpretation of study data
  • Pregnancy
  • Any other conditions that, in the opinion of the investigators, may compromise a participant's safety or the integrity of the study
  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: NCT01578798

Locations
United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Martin Angst
Investigators
Principal Investigator: Martin S Angst, MD Stanford University
  More Information

No publications provided

Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT01578798     History of Changes
Other Study ID Numbers: 22678
Study First Received: March 23, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014