- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01280253
Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture
November 11, 2016 updated by: Region Skane
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
999
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Skane
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Lund, Skane, Sweden, 22285
- Skåne University Hospital, Lund
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients presenting with hip fracture at University Hospital Lund Sweden
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- No consent can be obtained
- Non-operative management
- Followup through the Swedish National Quality for Hip fracture patients not possible
- High energy trauma
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mortality
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Morbidity
Time Frame: 30 day
|
Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications
|
30 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Bentzer, MD, PhD, Skåne University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
January 18, 2011
First Submitted That Met QC Criteria
January 19, 2011
First Posted (Estimate)
January 20, 2011
Study Record Updates
Last Update Posted (Estimate)
November 15, 2016
Last Update Submitted That Met QC Criteria
November 11, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USILAN-2
- 1837 (Region Skane ALF)
- 2010 (Fred Hutch/University of Washington Cancer Consortium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Upon reasonable request
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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