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

This study is currently recruiting participants.

Verified May 2013 by Stanford University

Sponsor:

Information provided by (Responsible Party):

Martin Angst, Stanford University

ClinicalTrials.gov Identifier:

NCT01578798

First received: March 23, 2012

Last updated: May 28, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 23, 2012

Last Updated Date

May 28, 2013

Start Date ^ICMJE

March 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01578798 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Whole blood and joint fluid

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing hip or knee replacement or back surgery.

Condition ^ICMJE

Surgical Trauma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Martin S Angst, MD	65-498-5109	ang@stanford.edu
Contact: Martha S Tingle, RN	650-724-2742	mtingle@stanford.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01578798

Other Study ID Numbers ^ICMJE

22678

Has Data Monitoring Committee

Responsible Party

Martin Angst, Stanford University

Study Sponsor ^ICMJE

Martin Angst

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Martin S Angst, MD

Stanford University

Information Provided By

Stanford University

Verification Date

May 2013

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

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