The Role of Fat Emboli in the Trauma Inflammatory Response

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02069327

Enrollment

Registered

2014-02-24

Start date

2012-11-30

Completion date

2014-11-30

Last updated

2019-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* n/a

Design outcomes

Primary

Measure	Time frame	Description
Inflammatory Response	One day	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.

Countries

United States

Outcome results