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Clinical Trials/NCT01578798
NCT01578798
Completed
Not Applicable

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

Martin Angst1 site in 1 country50 target enrollmentMarch 2012
ConditionsSurgical Trauma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Surgical Trauma
Sponsor
Martin Angst
Enrollment
50
Locations
1
Primary Endpoint
Mass cytometry of immune signaling events
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
July 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Martin Angst
Responsible Party
Sponsor Investigator
Principal Investigator

Martin Angst

Professor of Anesthesia

Stanford University

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Surgical Recovery Scale (SRS)(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.)
  • 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.)

Study Sites (1)

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