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

Completed

• Conditions: Surgical Trauma

• Registration Number: NCT01578798
• Lead Sponsor: Martin Angst

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 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

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-23
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mass cytometry of immune signaling events	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.	The primary molecular outcome is the fold change in phosphorylation of signaling proteins.

Secondary Outcome Measures

Name	Time	Method
Surgical Recovery Scale (SRS)	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	The surgical recovery scale is a validated questionnaire yielding a numerical score and assessing postoperative recovery.
Plasma cytokines	Blood samples will be drawn at baseline, 1 hour post-op, 24 hours post-op, 3 days post-op, and 6 weeks post-op.	The plasma concentration of plasma cytokines and chemokines will be measured with aid of a large protein array.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)	Data will be collected at baseline, daily through the hospitalization, and every 3 days for 6 weeks.	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.

Trial Locations

Locations (1)

Stanford University Hospital; 🇺🇸 Stanford, California, United States