TraumaNCT02021552
Genetic Polymorphisms & The Risk for Sepsis After Trauma
An observational study of Trauma, run by University of Washington at 1 site in United States.
Trial summary
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma
- What is being tested?
- blood sampling
- How many people
- 357 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort in which patients with severe injury, defined by combined anatomic injuries sufficient to require admission to the intensive care unit for treatment (blood transfusions, mechanical support of respiration) and intensive monitoring that is expected to be required for more than 24 hours, will be enrolled
Who may be able to join
- Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury
- ability to obtain a 5 ml blood sample
- Expected to be in the ICU for more than 24 hours
Who cannot join
- We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 998107
About this study
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.
Read the detailed description
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death
- Conditions
- Trauma
- Being tested
- blood sampling
- Keywords
- Trauma, Sepsis
- Medical subject headings
- Wounds and Injuries, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplingOther
5 ml blood sampling
| Study group | Role | What they receive |
|---|---|---|
| trauma patients | trauma patients 18 years or older requiring treatment in the ICU >24 hours. All subjects will undergo blood sampling. Receives: Other: blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.
The investigators will be studying whether baseline genetic difference can be used in the future to identify patients at high risk and conversely those at low risk for complicated post-traumatic infections.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant E. O'Keefe, University of Washington
- Investigators
- Grant O'Keefe, MD, Principal investigator, Professor; Dept of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02021552
- Sponsor's protocol ID
- 44109-A
- Status last verified
- Dec 2016
- First submitted
- 9 Dec 2013
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified samples and data will be available to other investigators at the discretion of the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms & The Risk for Sepsis After Trauma
- ClinicalTrials.gov ID
- NCT02021552
- Acronym / sponsor ID
- 44109-A
- Conditions
- Trauma
- Keywords
- Trauma, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Dec 2013 (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.
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.
Detailed description
The specific aim of this is to establish a cohort of severely injured patients admitted to our trauma center. Investigators will collect DNA, utilizing discarded blood samples, from 3000 injury victims in an effort to identify perhaps 50 - 100 single-nucleotide polymorphisms (SNP) (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| trauma patients | – | Other: blood samplingtrauma patients 18 years or older requiring treatment in the ICU >24 hours. All subjects will undergo blood sampling. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort in which patients with severe injury, defined by combined anatomic injuries sufficient to require admission to the intensive care unit for treatment (blood transfusions, mechanical support of respiration) and intensive monitoring that is expected to be required for more than 24 hours, will be enrolled
Key inclusion criteria (3 listed)
- Admitted to the Intensive Care Unit (ICU) at Harborview Medical Center after suffering a traumatic injury
- ability to obtain a 5 ml blood sample
- Expected to be in the ICU for more than 24 hours
Key exclusion criteria (1 listed)
- We will exclude subjects with chronic medical conditions for the reasons stated above as well as vulnerable populations (children, pregnant females, and prisoners)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling5 ml blood sampling | Other | trauma patients |
Primary outcome
Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death.
Time frame: 3 years
The investigators will be studying whether baseline genetic difference can be used in the future to identify patients at high risk and conversely those at low risk for complicated post-traumatic infections.
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 7 Dec 2016.
- Individual participant dataSharing planned: Yes. De-identified samples and data will be available to other investigators at the discretion of the Principal Investigator.
Related trials for Trauma
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
RecruitingObservational study
Midwest Birth Outcomes and Indigenous American Pregnancy
Pregnancy
Active, not recruitingPhase 1/2
A Study of Andecaliximab in People With Spinal Cord Injury at Risk for Bone Growth Outside of the Normal Skeleton.
Heterotopic Ossification (HO)
RecruitingPhase 4
Indigotindisulfonate Sodium as an Aid in Determination of Ureteral Patency in Patient's With Renal Impairment
Ureter Injury
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
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.
Grant O'Keefe, MD principal investigator
Professor; Dept of Surgery
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 Trauma, run by University of Washington 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 3 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 7 Dec 2016. 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?
Investigators aim to identify up to 100 single-nucleotide polymorphisms (out of 1000s) that can be used, when taken together, to identify patients at highest risk for developing complicated sepsis and death. (time frame: 3 years). 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 7 Dec 2016.