The Role of Fat Emboli in the Trauma Inflammatory Response | NCT02069327

Studies
The Role of Fat Emboli in the Trauma Inflammatory Response

NCT02069327

Sponsor

Poudre Valley Health System

Status

Completed

Last Update Posted

Mar 20, 2019Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Femoral Fracture

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Jul 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Feb 3, 2014

First Submission Date that Met QC Criteria

Feb 19, 2014

First Posted Date

Feb 24, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Julie Dunn, M.D., Trauma Research Director / Trauma Surgeon, Poudre Valley Health SystemPrincipal Investigator

Lead Sponsor

Poudre Valley Health SystemOTHER

Collaborators

Name	Class
Colorado State University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

9Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Julie Dunn, M.D.	Poudre Valley Health System	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Center of the Rockies		Loveland	Colorado	80538	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005264	Femoral Fractures
C564245	Platelet Glycoprotein IV Deficiency
D004617	Embolism
D004620	Embolism, Fat
D014947	Wounds and Injuries
D050723	Fractures, Bone

Ancestor Terms

ID	Term
D007869	Leg Injuries
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

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Browse Branches

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