NCT02069327

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

February 3, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

February 3, 2014

Last Update Submit

March 18, 2019

Conditions

Femoral Fracture

Keywords

FemurFatEmboliBoneMarrowproteomicproteomicsmetabolomicsmetabolomicinflammatorycytokinechemokineanaphlylatoxinThromboelastographyMedical Center of the RockiesFat Embolism SyndromeInjuryFractureMetaboliteMCRTEGFES

Outcome Measures

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.

    One day

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • n/a

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center of the Rockies

Loveland, Colorado, 80538, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Bone marrow Blood specimen (\~4 teaspoons)

MeSH Terms

Conditions

Femoral FracturesPlatelet Glycoprotein IV DeficiencyEmbolismEmbolism, FatWounds and InjuriesFractures, Bone

Condition Hierarchy (Ancestors)

Leg InjuriesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Officials

  • Julie Dunn, M.D.

    Poudre Valley Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trauma Research Director / Trauma Surgeon

Study Record Dates

First Submitted

February 3, 2014

First Posted

February 24, 2014

Study Start

November 1, 2012

Primary Completion

July 1, 2014

Study Completion

November 1, 2014

Last Updated

March 20, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)