Hip FractureNCT01280253
Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture
An observational study of Hip Fracture, run by Region Skane at 1 site in Sweden.
Trial summary
The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fracture
- How many people
- 999 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients presenting with hip fracture at University Hospital Lund Sweden
Who may be able to join
- Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden
- Informed consent
- Blood sampling within 3 hrs of first contact with healthcare
Who cannot join
- No consent can be obtained
- Non-operative management
- Followup through the Swedish National Quality for Hip fracture patients not possible
- High energy trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?
The objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.
- Conditions
- Hip Fracture
- Keywords
- Predictor, outcome, biochemical
- Medical subject headings
- Hip Fractures
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 30 days
Secondary outcomes (1)
Morbidity
Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 999 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Anna and Edwin Berger Foundation
- Responsible party
- Sponsor
- Investigators
- Peter Bentzer, MD, PhD, Principal investigator, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01280253
- Sponsor's protocol ID
- USILAN-2
- Other IDs
- 2010, 1837
- Status last verified
- Nov 2016
- First submitted
- 18 Jan 2011
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Upon reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?
- ClinicalTrials.gov ID
- NCT01280253
- Acronym / sponsor ID
- USILAN-2
- Conditions
- Hip Fracture
- Keywords
- Predictor, outcome, biochemical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 999 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Anna and Edwin Berger Foundation
- Study start
- Jan 2011
- Primary completion
- Aug 2014 (actual)
- First posted
- 20 Jan 2011 (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 objective of the study is to identify biochemical predictors of morbidity and mortality in patients suffering from hip fracture. For this purpose blood samples are collected prehospitally or in the emergency department in patients with a suspected hip fracture. During the hospital stay medical history, anesthesiological management recorded. In addition, american society of anesthesiology physiological score (ASA), revised cardiac risk index (RCRI), and POSSUM score is calculated. Morbidity and mortality is recorded " in house", after 30 days, after 4 months and after 1 year. Biochemical predictors of outcome will be evaluated with logistic regression analysis. Biochemical predictors include pro-brain natriuretic peptide, lactate, pro-calcitonin, adrenomedullin, copeptin, cystatin c. The predictive value of the potential markers will be compared to that of ASA, RCRI and POSSUM.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients presenting with hip fracture at University Hospital Lund Sweden
Key inclusion criteria (3 listed)
- Patients presenting with out of hospital hip fracture at University Hospital Lund Sweden
- Informed consent
- Blood sampling within 3 hrs of first contact with healthcare
Key exclusion criteria (4 listed)
- No consent can be obtained
- Non-operative management
- Followup through the Swedish National Quality for Hip fracture patients not possible
- High energy trauma
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
Mortality
Time frame: 30 days
1 secondary outcome
Morbidity
Time frame: 30 day
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 15 Nov 2016.
- Individual participant dataSharing planned: Yes. Upon reasonable request
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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.
Peter Bentzer, MD, PhD principal investigator
Skane University Hospital
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 Hip Fracture, run by Region Skane at 1 site in Sweden.
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 4 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 15 Nov 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 Sweden. 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?
Mortality (time frame: 30 days). 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 15 Nov 2016.