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

Surgical Trauma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578798
• Other study ID #: 22678
• Status: Completed
• Phase: N/A
• First received: March 23, 2012
• Last updated: October 29, 2013
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Surgical Trauma
• Wounds and Injuries

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	Mass cytometry of immune signaling events	The primary molecular outcome is the fold change in phosphorylation of signaling proteins.	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.	No
Secondary	Surgical Recovery Scale (SRS)	The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	No
Secondary	Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Western Ontario and McMaster Universities Arthritis Index is a validated questionnaires yielding a numerical score and assessing functional status and pain in patients suffering from osteoarthritis of the hip.	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	No
Secondary	Plasma cytokines	The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.	Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.	No