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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University
ClinicalTrials.gov Identifier:
NCT01578798
First received: March 23, 2012
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  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:

MedlinePlus related topics: Injuries Wounds
U.S. FDA Resources

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 ]
    Primary outcome is the fold change in phosphorylation.


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

  • 40-item Questionnaire of Recovery (QoR40) [ Time Frame: Questionnaire data will be collected at BL and daily through the hospitalization period. ] [ Designated as safety issue: No ]
    The QoR 40 is a validated questionnaire yielding a numerical score and measuring immediate postoperative recovery in hospitalized patients.

  • 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.

  • 36-item Short Form Health Survey (SF 36) [ 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 SF 36 is a validated questionnaire yielding a numerical score and assessing general health.

  • 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 51 plasma cytokines and chemokines will be measured.


Biospecimen Retention:   Samples With DNA

Whole blood and joint fluid


Estimated Enrollment: 50
Study Start Date: March 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing hip or knee replacement or back surgery.

Criteria

Inclusion Criteria:

  • 18 - 80
  • Men and women
  • Planning to undergo hip, knee or back surgery

Exclusion Criteria:

  • Any systemic disease that might compromise the immune system (eg: lupus)
  • Diagnosis of cancer
  • Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.
  • Unwilling to sign informed consent
  Contacts and Locations
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: May 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on May 19, 2013