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CompletedNCT01578798Updated Oct 30, 2013

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

An observational study in Surgical Trauma, sponsored by Martin Angst. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-10-30.

Sponsored by Martin Angst · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 90 Years
Sex
All
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Study 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.

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Conditions studied

  • Surgical Trauma
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In context

Lead sponsor

Martin Angst is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing primary hip replacement.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 - 90
  • Planning to undergo hip surgery
  • Fluent in English
  • Willing and able to sign informed consent and HIPAA authorization

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Mass cytometry of immune signaling events

    The primary molecular outcome is the fold change in phosphorylation of signaling proteins.

    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.

Secondary outcomes

  1. Surgical Recovery Scale (SRS)

    The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.

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

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    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.

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

  3. Plasma cytokines

    The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.

    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.

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Study locations

1 site
  • Stanford University Hospital
    Stanford, California 94305, United States
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References and documents

Publications

  • 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. PubMed 25253674 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 30, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01578798
Lead sponsor
Martin Angst
Responsible party
Martin Angst (Professor of Anesthesia, Stanford University) — Sponsor-investigator
First posted
Apr 17, 2012
Start date
Mar 2012
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Oct 30, 2013

Study contacts

Martin S Angst, MD
principal investigator · Stanford University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.

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