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

Sponsor

Martin Angst (Other)

Overall Status

Completed

CT.gov ID

NCT01578798

Collaborator

(none)

Enrollment

Location

Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Trauma

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Jul 1, 2013

Actual Study Completion Date :

Jul 1, 2013

Outcome Measures

Primary Outcome Measures

Mass cytometry of immune signaling events [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.

Secondary Outcome Measures

Surgical Recovery Scale (SRS) [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.
Western Ontario and McMaster Universities Arthritis Index (WOMAC) [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.
Plasma cytokines [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University Hospital	Stanford	California	United States	94305

Sponsors and Collaborators

Martin Angst

Investigators

Principal Investigator: Martin S Angst, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martin Angst, Professor of Anesthesia, Stanford University

ClinicalTrials.gov Identifier:

NCT01578798

Other Study ID Numbers:

22678

First Posted:

Apr 17, 2012

Last Update Posted:

Oct 30, 2013

Last Verified:

Oct 1, 2013

Additional relevant MeSH terms:

Wounds and Injuries

Study Results

No Results Posted as of Oct 30, 2013