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OpenTrials
Completed

NCT Number: NCT01578798

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

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.

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Key information

Conditions

Surgical Trauma

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University Hospital

Stanford, California, 94305, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mass cytometry of immune signaling events

    Time frame: 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 outcomes

  1. Surgical Recovery Scale (SRS)

    Time frame: 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.

  2. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Time frame: 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.

  3. Plasma cytokines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Martin Angst

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2012
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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