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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01578798
Other study ID # 22678
Secondary ID
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


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
See also
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