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Preoperative Biochemical Predictors of Outcome in Patients With Hip Fracture

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ClinicalTrials.gov Identifier: NCT01280253
Recruitment Status : Completed
First Posted : January 20, 2011
Last Update Posted : November 15, 2016
Sponsor:
Collaborator:
Anna and Edwin Berger Foundation
Information provided by (Responsible Party):
Region Skane

Study Description
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Brief 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. 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.

Condition or disease
Hip Fracture

Study Design
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Study Type : Observational
Actual Enrollment : 999 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Can Biochemical Tests Predict Outcome in Patients With Hip Fracture?
Study Start Date : January 2011
Actual Primary Completion Date : August 2014

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Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Morbidity [ Time Frame: 30 day ]
    Infectious complications Cardiovascular complications Thromboembolic complications Respiratory complications Renal complications Surgical complications


Biospecimen Retention:   Samples Without DNA
Litium-heparin plasma EDTA plasma

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients presenting with hip fracture at University Hospital Lund Sweden
Criteria

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
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280253


Locations
Sweden
Skane University Hospital, Lund
Lund, Skane, Sweden, 22285
Sponsors and Collaborators
Region Skane
Anna and Edwin Berger Foundation
Investigators
Principal Investigator: Peter Bentzer, MD, PhD Skane University Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT01280253     History of Changes
Other Study ID Numbers: USILAN-2
2010 ( Other Grant/Funding Number: Anna och Edwin Berger Foundation )
1837 ( Other Grant/Funding Number: Region Skane ALF )
First Posted: January 20, 2011    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon reasonable request

Keywords provided by Region Skane:
Predictor
outcome
biochemical

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
 Femoral Fractures
Hip Injuries
Leg Injuries