Femoral FractureNCT02069327
The Role of Fat Emboli in the Trauma Inflammatory Response
An observational study of Femoral Fracture, run by Poudre Valley Health System at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Femoral Fracture
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients undergoing a tibial or femoral fracture procedure in the operating room.
Who may be able to join
- Patients undergoing a tibial or femoral fracture procedure in the operating room.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical Center of the Rockies
Loveland, Colorado, 80538
About this study
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.
- 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
- Medical subject headings
- Femoral Fractures, Platelet Glycoprotein IV Deficiency, Embolism, Embolism, Fat, Wounds and Injuries, Fractures, Bone
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poudre Valley Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado State University
- Responsible party
- Principal investigator, Julie Dunn, M.D., Poudre Valley Health System
- Investigators
- Julie Dunn, M.D., Principal investigator, Poudre Valley Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069327
- Sponsor's protocol ID
- Fat Emboli
- Status last verified
- Mar 2019
- First submitted
- 3 Feb 2014
- Last updated
- 20 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Fat Emboli in the Trauma Inflammatory Response
- ClinicalTrials.gov ID
- NCT02069327
- Acronym / sponsor ID
- Fat Emboli
- Conditions
- Femoral Fracture
- Keywords
- Femur, Fat, Emboli, Bone, Marrow, proteomic, proteomics, metabolomics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Poudre Valley Health SystemUniversity, hospital or other
- Collaborators
- Colorado State University
- Study start
- Nov 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 24 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing a tibial or femoral fracture procedure in the operating room.
Key inclusion criteria (1 listed)
- Patients undergoing a tibial or femoral fracture procedure in the operating room.
Key exclusion criteria (1 listed)
- n/a
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Dunn, M.D. principal investigator
Poudre Valley Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoral Fracture, run by Poudre Valley Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Response (time frame: One day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2019.