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CompletedNCT02069327Updated Mar 20, 2019

The Role of Fat Emboli in the Trauma Inflammatory Response

An observational study in Femoral Fracture, sponsored by Poudre Valley Health System. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2019-03-20.

Sponsored by Poudre Valley Health System · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
9
Sex
All
01

Study summary

This is an observational study designed to investigate the role of fat emboli in patients who are undergoing a tibial or femoral fracture procedure in the operating room. The purpose of this study is to obtain samples of bone marrow and blood during tibial or femoral fracture procedures to understand the inflammatory response.

Read the detailed description

Bone marrow is routinely removed during a tibial or femoral fracture procedure; researchers will take samples for this study from bone marrow that has already been removed as part of this procedure. No additional marrow samples will be taken as part of this research study. Also, researchers will collect blood (about 4 teaspoons) for testing inflammatory response and coagulation. Researchers may need to insert an additional line to collect your blood.

02

Conditions studied

  • Femoral Fracture

Keywords

  • Femur
  • Fat
  • Emboli
  • Bone
  • Marrow
  • proteomic
  • proteomics
  • metabolomics
  • metabolomic
  • inflammatory
  • cytokine
  • chemokine
  • anaphlylatoxin
  • Thromboelastography
  • Medical Center of the Rockies
  • Fat Embolism Syndrome
  • Injury
  • Fracture
  • Metabolite
  • MCR
  • TEG
  • FES
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In context

Embolism

707 studies on the registry are indexed under Embolism; 74 are open to participants now.

This study's enrollment of 9 is below the median of 353 across 310 observational studies indexed under Embolism.

Browse Embolism studies →

Lead sponsor

Poudre Valley Health System is the lead sponsor of 15 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing a tibial or femoral fracture procedure in the operating room.

Inclusion criteria

  • Patients undergoing a tibial or femoral fracture procedure in the operating room.

Exclusion criteria

Exclusion Criteria:

  • n/a
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
9 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Inflammatory Response

    Samples will be tested using proteomic and metabolomic assays from samples of bone marrow reamed during intramedullary (IM) femoral nailing. Blood samples drawn at the time of IM nailing will be tested to determine if clinically relevant amounts of marrow containing these inflammatory mediators are released into the bloodstream.

    Time frame: One day

07

Study locations

1 site
  • Medical Center of the Rockies
    Loveland, Colorado 80538, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02069327
Lead sponsor
Poudre Valley Health System
Collaborators
Colorado State University
Responsible party
Julie Dunn, M.D. (Trauma Research Director / Trauma Surgeon, Poudre Valley Health System) — Principal investigator
First posted
Feb 24, 2014
Start date
Nov 2012
Primary completion
Jul 2014
Completion
Nov 2014
Last update
Mar 20, 2019

Study contacts

Julie Dunn, M.D.
principal investigator · Poudre Valley Health System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.

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