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

NCT ID: NCT01578798

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Surgical Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Martin Angst

OTHER

Sponsor Role lead

Responsible Party

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Martin Angst

Professor of Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Martin S Angst, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University Hospital

Stanford, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 25253674 (View on PubMed)

Other Identifiers

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22678

Identifier Type: -

Identifier Source: org_study_id