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

October 29, 2013 updated by: Martin Angst
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing primary hip replacement.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The primary molecular outcome is the fold change in phosphorylation of signaling proteins.
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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Recovery Scale (SRS)
Time Frame: Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.
The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.
Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.
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.
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.
Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.
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.
The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.
Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin Angst

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 23, 2012

First Submitted That Met QC Criteria

April 16, 2012

First Posted (Estimate)

April 17, 2012

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22678

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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