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Optimization of Time-of-Flight Mass Cytometry (CyTOF) Analysis for Evaluation of Immune Changes Following Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01882569
Recruitment Status : Completed
First Posted : June 20, 2013
Last Update Posted : May 4, 2016
Sponsor:
Information provided by (Responsible Party):
Martin Angst, Stanford University

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 is to use a single cell flow cytometry approach to characterize the cellular and molecular mechanisms involved in the inflammatory response to surgical trauma.

Condition or disease
Surgical Trauma

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Detection of Immune Changes as a Result of Surgical Trauma in Human Back Surgery Subjects: Optimization of CyTOF Analysis
Study Start Date : May 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Back surgery



Primary Outcome Measures :
  1. Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells [ Time Frame: Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge ]
    This is an exploratory study.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Generally healthy patients undergoing back surgery
Criteria

Inclusion Criteria:

  1. Ages 18 - 90
  2. Men and women
  3. Undergo back surgery

Exclusion Criteria:

  1. Any systemic disease that might compromise the immune system (e.g. lupus)
  2. Current diagnosis of cancer
  3. Any condition that, in the opinion of the investigator, might compromise the integrity of the study or safety of the participant.
  4. Unwilling to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01882569


Locations
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United States, California
Stanford University Hospital
Stanford, California, United States, 94305
Sponsors and Collaborators
Martin Angst
Investigators
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Principal Investigator: Martin S Angst, MD Stanford University SOM
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Responsible Party: Martin Angst, Professor of Anesthesia, Stanford University
ClinicalTrials.gov Identifier: NCT01882569    
Other Study ID Numbers: 24014
First Posted: June 20, 2013    Key Record Dates
Last Update Posted: May 4, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Wounds and Injuries