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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01882569
Other study ID # 24014
Secondary ID
Status Completed
Phase N/A
First received June 18, 2013
Last updated May 2, 2016
Start date May 2012
Est. completion date September 2014

Study information

Verified date May 2016
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority USA: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date September 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Stanford University Hospital Stanford California

Sponsors (1)

Lead Sponsor Collaborator
Martin Angst

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Numerical (cell frequencies) and functional (phosphorylation of signaling proteins and transcription factors) changes of all circulating immune cells This is an exploratory study. Immediately before to surgery, 1 hour after surgery, 24 hours after surgery, and day of hospital discharge No
See also
  Status Clinical Trial Phase
Completed NCT01578798 - Detection of Immune Changes as a Result of Surgical Trauma in Human Subject N/A
Completed NCT06405659 - Immediate Fever During Anaesthesia Recovery After Surgical Procedure With Scoliosis