The Role of Fat Emboli in the Trauma Inflammatory Response

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.

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Key information

Conditions

Femoral Fracture Cardiovascular Diseases Embolism Embolism and Thrombosis Embolism, Fat Femoral Fractures Fractures, Bone Leg Injuries Platelet Glycoprotein IV Deficiency Vascular Diseases Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary outcomes

Inflammatory Response

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Poudre Valley Health System

Other

Collaborators

Colorado State University

Registry information

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Feb 24, 2014
Registry last updated: Mar 20, 2019

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.

Published trials that share one or more normalized conditions with this study.

Completed