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

NCT01578798 | Completed

• 1 other identifier: 22678
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Trauma

Outcome Measures

Primary Outcomes (1)

• Mass cytometry of immune signaling events

  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 Outcomes (3)

• Surgical Recovery Scale (SRS)

  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)

  Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.

• 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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing primary hip replacement.

You may qualify if:

• Planning to undergo hip surgery
• Fluent in English
• Willing and able to sign informed consent and HIPAA authorization

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Angst: lead

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Related Publications (1)

• Gaudilliere B, Fragiadakis GK, Bruggner RV, Nicolau M, Finck R, Tingle M, Silva J, Ganio EA, Yeh CG, Maloney WJ, Huddleston JI, Goodman SB, Davis MM, Bendall SC, Fantl WJ, Angst MS, Nolan GP. Clinical recovery from surgery correlates with single-cell immune signatures. Sci Transl Med. 2014 Sep 24;6(255):255ra131. doi: 10.1126/scitranslmed.3009701.

  PMID: 25253674 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

Study Officials

• Martin S Angst, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesia

Study Record Dates

• First Submitted: March 23, 2012
• First Posted: April 17, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: October 30, 2013

Record last verified: 2013-10

Locations

US (1)