NCT01882569

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1.8 years

First QC Date

June 18, 2013

Last Update Submit

May 2, 2016

Conditions

Surgical Trauma

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Back surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Generally healthy patients undergoing back surgery

You may qualify if:

  • Ages 18 - 90
  • Men and women
  • Undergo back surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University Hospital

Stanford, California, 94305, United States

Location

Study Officials

  • Martin S Angst, MD

    Stanford University SOM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Anesthesia

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 20, 2013

Study Start

May 1, 2012

Primary Completion

February 1, 2014

Study Completion

September 1, 2014

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

US(1)