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

March 23, 2012
October 29, 2013
March 2012
July 2013   (final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT01578798 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
Detection of Immune Changes as a Result of Surgical Trauma in Human Subject
Detection of Immune Changes as a Result of Surgical Trauma in Human Subject

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood

Non-Probability Sample

Patients undergoing primary hip replacement.

Surgical Trauma
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01578798
22678
No
Martin Angst, Stanford University
Martin Angst
Not Provided
Principal Investigator: Martin S Angst, MD Stanford University
Stanford University
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP